Site Quality Head, Large Molecules

Ola Adel, Site Quality Head Stein Steriles

Over *9 years of experience in the pharmaceutical field; 18 of which in Novartis, being Self-directed, having Quality mind-set, always looking for improvement and best practices, motivated by challenge, striving for excellence and having the ability to work cross culture and cross functionally characterized with having profound knowledge of GMP, regulatory requirements and latest trends.

2021 until date: Site Quality Head Stein Steriles, Large Molecules– Novartis Switzerland

2017 – 2020: Head Compliance and Quality systems– Novartis Switzerland

2012 – 2017: Quality Compliance Head – Novartis PharmOps Egypt.

2011 – 2012: Sterile, liquids and Semisolids Production - Novartis PharmOps Egypt.

2009 – 2011: Central QA Expert- Novartis PharmOps Egypt.

2007 – 2009: QA Specialist- Novartis PharmOps Egypt.

2004 – 2007: QC, Analytical testing, stability management and cleaning validation - Novartis PharmOps Egypt.

Detailed Experience:

2021 until date: Site Quality Head Stein Steriles

Achievements:

Successful launch and production of Comirnaty vaccine for Pfizer BioNtech.

Successful launch and production of Ensovibep for COVID-19 treatment.

Achieving 1.2 million USDs savings within Quality organization versus past years leading over than 260 employees.

Driving Digitalization within Quality department implementing automated solution with Growth Direct and automated sample preparation

Successfully Passing FDA inspections, Russian HA inspection, EMA, EAEU and Swiss Medic with a very good outcome.

Having full control over Budget and Headcount together with sustainable achievement of Key Quality Indicators versus Target.

Main responsibilities:

To provide managerial leadership for the site in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies.

Develop and lead the quality teams at the site in line with the Novartis leadership framework and cultural aspirations.

Operational

Leadership of Site Quality organization

Implement, comply with, and govern practices prescribed in the Novartis Manufacturing Manual

Quality oversight of GxP site functions

Acts as site Technical Responsible Person (Qualified Person)

Ensure product quality

Ensure regulatory compliance and implementation of corporate quality standards and regulations

Ensure status of local HA registration

Preparation of Site Master File for regulatory purposes

Site quality risk assessment

Quality Management Review

Approval or rejection of raw materials, facilities, utilities, preliminary, finished product or stability samples

Approval of PQR/APQR

Ensure exception management

Ensure complaint investigation

Ensure training execution across site

Ensure DI, eCompliance and compliance with all cGxP and all regulatory requirements for manufacturing, control and distribution operations

Ensure adherence to HSE guidelines and requirements

Collaboration in GxP internal audits

Ensure fulfillment of internal/external audit and inspection plans

Ensure any collaborations with 3rd parties are performed with adequate Quality Assurance Agreements in place

Ensure any additional local legal requirements are fulfilled

Ensure Business continuity management

Leadership & Culture

Drives the talent agenda: Leads people processes through recruitment, training, coaching and performance to meet all operation requirements sustaining both site and quality unit competitiveness and diversity. Supports a robust career path deployment and succession plan for the unit and site

Invest time in personally developing and coaching talents

Actively support and promote talent exchange for the benefit of the individuals and organization

Ensure the consistency between career development processes and the business strategy

Support the T&L organization by identifying and reviewing the appropriate list of training for all in-scope associates

Ensure that associates are qualified for a GMP task prior to independent performance

Monitor overall training compliance for in-scope associates

Identify and maintain a list of subject matter experts for in-scope areas of expertise

Create a work environment that enables high employee engagement

Role model the culture aspiration of being Curious, Inspired and Un-bossed and ensure leaders and associates are aware and aligned on expectations and hold them accountable for success of culture journey

HSE

Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the site

Ensure overall inspection readiness for area of responsibility.

Guarantee the effectiveness of the Business Continuity Plan

Being part of the site crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the Site Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.

Responsible for participating in initial training and retraining

HSE incidents reporting & action follow-up

2017 – 2020: Head Compliance and Quality Systems– Novartis Stein Switzerland.

Achievements:

Successfully Passing FDA inspections, Russian HA inspection, EMA, EAEU and Swiss Medic with a very good outcome.

Managed to achieve the official approval for the new Launch facility for Solids commercial manufacturing and for the Cell and Gene therapy.

Building high performing team with diverse capabilities and competences that led to extraordinary results being very adept at managing difficult employees and turning their energies towards higher performance.

Reducing complexity, improving the culture, optimizing processes and changing people mindset.

Supporting all global projects, always acting as a pilot site for all new initiatives and as a flagship site for all Novartis sites.

Leading the SOP simplification project, reduction of local SOPs by 30%.

Enforcing SME concept, knowledge transfer and people empowerment.

Certification of suppliers resulting in reduction of the number of tests performed on incoming material at our laboratories.

Increasing the efficiency of our QC stuff by saving 30 minutes per day, always thinking out of the box.

Main responsibilities:

Liaise with global and platform compliance and quality system teams and management, leadership team in

order to provide and collect input and advices.

Assures quality and regulatory compliance of operations and systems and that processes and standards are aligned with Global and Platform requirements.

Accountable for the effective use of resources to meet objectives in line with global guidance.

Lead complex trouble shooting, escalations, issue management requiring interpretation of complex information and persuasion both internally with other area of the business and with the leadership team and / or externally. Will proactively identify and address any compliance issues.

Provide expert advice and appropriate technical support/solution on a wide range of issues / matters related to own area.

Amongst other topic, I am responsible with my team for:

oGlobal Quality Module and GOPs are properly implemented in Quality Systems

oLocal support to end users in the administration of the Quality Systems.

oDevelopment, Maintenance and reporting of Quality Metrics to monitor overall compliance.

oExecution of Quality Plan and various quality/compliance programs and supporting regulatory compliance.

oLeading and coordination of the complete on site and paper based audit and inspection activities.

oMonitoring and oversight activities based on risk assessments, results of audit findings, outcomes from investigations, and other sources including regulatory enforcement trends.

oOversight of the Deviation, CAPA, Change Control, and Document Management systems.

oAccountable for the regular Management Reviews (Quarterly Review Board).

oAccountable for compliance to Novartis escalation processes, timelines of local and global HA by coordination, execution, follow-up and documentation of local and joint local / global Quality Assessments and Recall Committee meetings.

oEnsure timely compilation of APR/PQRs in accordance with prescriptions of applicable procedures as well as that follow up activities if necessary are defined, followed through and documented.

oLeads site Change control system

oEnsure Self-Inspections program

oResponsible for the management of the supplier quality activities.

oResponsible that all activities in terms of qualification and validation Plans that include process validation, packaging validation, cleaning validation, equipment qualification, utilities and facilities qualification and computer system validation associated with all Quality Investigations, projects, transfers and launches are provided on time

oEnsure all technical changes (QA gate approver and assesses all changes for their QA relevance).

oBlockage and release of a production unit after a maintenance shut down or deviations.

oRegulatory / Reg-CMC activities.

oTimely review and approval of non-batch related deviations.

oTimely review and approval of CPV reports.

oSupport the implementation of Novartis data integrity strategy particularly via the CSV / e-compliance aspects.

Leading, a team of about 18 FTE as well have budget responsibility for Compliance department.

Provide leadership, direction and support to the people within the QA Compliance and Quality Systems department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.

Manage human resources in the QA Compliance and Quality Systems department (recruitment, retention, training and personal development, wages, resource assessment, performance management etc.)

Acts as Deputy “Fachtechnisch verantwortliche Person” / Qualified Person for Technical Operations acc. to art. 5 and 10 of the Swiss "Arzneimittelbewilligungsverordnung”

2012 – 2017: Quality Compliance Head – Novartis PharmOps Egypt.

Achievements:

Led the Quality compliance team through very tough time passing successfully 7 consecutive audits e.g. Global Compliance and auditing, Rolling Engineering Assurance, HA Inspections ….. Where 6 of the technical experts in the team had job rotations to other sites or functions in the organization either in NTO, ESO QA, CPO QA & other sites.

Giving international support to other sites passing their planned audits e.g. Algeria, South Africa and Turkey.

Passing all regulatory authority inspections with zero critical or major observations.

Successfully handling all our suppliers and distribution centers through cross functional teams.

Managing to Pass NAFDAC and Global GSK Audits with status Good and Zero observations.

Cross-Functional engagement in all Quality systems and standards across all sites, Identifying new procedures, Reviewing and Approving Global Operating Procedures e.g. Deviation and Complaints GOPs, Sharing best practice in Quality manual implementation, Supplier risk assessments and Change control.

Fulfilling all gap remediation against FDA, WHO, EMA, MHRA, ANVISA and Russian HA requirements.

Main responsibilities:

Assuring product quality and regulatory Compliance maintaining zero recalls.

Issuing and follow up of Quality plan, participating in Long term plan & performing site quality risk assessment.

Assigned the SPOC for all sales and operational meeting and to communicate with all sectors, sales and distribution centers.

Responsible for supplier management and setting all the quality/supply agreements.

Updating Product Improvement portfolio and assuring product continuous improvement.

Assuring 100% data integrity, managing equipment qualification and computer system validation.

Managing supplier qualification and supplier performance review.

Improving product quality and annual reviews “APQR” to achieve sustainable product performance.

Working to achieve Quality as a competitive advantage.

Trending of Deviations, complaints, CAPAs and OOS for the leverage of quality and to prevent any potential problems.

Assure execution of all compliance systems/activities required to be implemented according to GMP quality manual standard requirements.

System-owner and management / follow up of QM –tracking –systems e.g. AQWA, ESOPs and validation/qualification master plans.

Managing an effective change control system in all areas, thereby ensuring a high regulatory compliance status in all our products and processes.

Continuous monitoring and data trending of all GMP relevant areas, including status report, KPIs,reports to management and derived action plans.

Assuring product security and Compliance.

Leading self-inspections and QA oversight, continually working to improve strengths and weaknesses.

Responsible for all Quality management systems, always looking for better ways to do things.

2011 – 2012: Sterile, liquids and Semisolids Production Expert - Novartis PharmOps Egypt.

Achievements:

Improve cooperation within the team and with other teams, working to build up employee’s morale.

Being a motivator, building my people and acting as a leader and a role model not only a manager constantly providing coaching and direction.

Finalizing the batch right first time project for master batch records.

Main responsibilities:

Execute process validation.

Participate in reallocation of products into different work centers.

Troubleshoot and improve process (product).

Participate in root cause analysis in case of deviations, problem solving as well as process improvement.

Implement solutions for problematic processes and products.

Coach personnel through the Lean manufacturing.

Transfer of technical knowledge to team members.

Give support to technical training if needed.

Support improvement for line efficiencies.

Issuing and update master batch records.

Products\process recipe management for equipment.

Participate in product transfers and new introductions.

Review and approve the manufacturing documents (e.g. filled master batch record, deviation reports, logbooks etc...) within a process unit to ensure continuous operational running.

Encourage, evaluate, assist and implement the continuous improvement ideas to achieve productivity improvement within the process unit.

Support execution of firmed finite schedule according to lean principles to achieve agreed upon KPIs.

Contribute to the Performance Management process as well as training and development identification to team members

Responsible for day-to-day implementation of cGMP, HSE & Novartis guidelines within the operational units.

2009 – 2011: Central QA Expert- Novartis PharmOps Egypt.

Achievements:

Fulfilling the Quantic Gap assessment for Suffern in the US site.

Handling the FDA commitments for Novartis.

Covering all gap remediation against all the 483s reports issued.

Effective communication with all sectors on the local and global level constantly exposed to challenges with different experts having diverse background of knowledge and perspectives. Successfully handling all regulatory issues with different authorities gaining the mutual trust and maintaining our company's image the best among all others in the field.

Improve Deviation and Non-Conforming handling process.

Introduction of new process and template, keeping a good comprehensive knowledge of GMP regulation and requirements.

Positive contribution in the implementation of the quality system in order to produce high product quality.

Main responsibilities:

Assure implementation of product quality reviews (PQR) reports for the process units to enable process improvement.

Provide proactive compliance support to ensure successful product launches.

Oversee GMP training.

Ensuring overall regulatory compliance and business continuity.

Assure implementation of pest control within the site.

Support the quality related elements for new launches, transfers of product to ensure continuity of supply.

Manage audits and compliance support program for assigned contractors and distributors.

Responsible for the handling of Complaints, Counterfeits and Recalls.

Manage quality agreements for contractors.

Performing audits as lead auditor assuring report in place, action plan in place and follow up.

Supplier approval and qualification.

Batch record review and product release of all dosage forms in the manufacturing site and at the third parties.

Significant experience working cross-functionally and in global teams.

Handling process complaints\ deviations to ensure timely and accurate investigation and feedback for locally manufactured products and at the third parties.

2007 – 2009: QA Specialist- Novartis PharmOps Egypt.

Achievements:

Full implementation of the new system for Change Control (AQWA):

Core team member in the LI@N project: Responsible for batch Management and Certification module.

Project manager of LI@N retrofit project (responsible for the batch management and certification)

Main responsibilities:

Full implementation of Change Control system acting as site change coordinator.

Batch record review and product release of all dosage forms in the manufacturing site and at the third parties.

Keeping the compliance of all SOPs and training files for the personnel.

Improve Deviation and Non-Conforming handling process, Introduction of new process and template, keeping a good comprehensive knowledge of GMP regulation and requirements. Positive contribution in the implementation of the quality system in order to produce high product quality.

Assure the implementation of returned goods process.

Supplier approval and qualification.

Implement and deliver GMP training.

Issue product quality reviews (PQR) reports.

2004 -2007: QC, Analytical testing, stability management and cleaning validation - Novartis PharmOps Egypt.

Expert in analytical method validation, cleaning validation and stability management.

Participate in the LI@N laboratory information at Novartis project: Responsible for batch Management and Certification module.

Project manager for the LI@N Retrofit.

Analytical method transfer and product launches.

Technical experience in handling of all the laboratory affairs either related to GLP&HSE, handling of reagents, equipment.

Education:

Institution

[ Date from - Date to ]

Degree(s) or Diploma(s) obtained:

Ain Shams University [ 1998 - 2003 ]

Bachelor Degree in Pharmaceutical Science and clinical pharmacy.

American University in Cairo [ 2005 - 2006 ]

Total Quality Management Diploma

Novartis, Basel [ 2011]

Leading at the front line

RITI Institute [September 2011]

Train the trainers Diploma

American University in Cairo [February-June 2013]

Green belt in Lean & Six sigma.

American University in Cairo [October 2014-May 2015]

Black belt in Lean & Six sigma.

ESLSCA PARIS [ 2015 - 2017 ]

Master in Business Administration

Novartis, Basel [ 2016 - 2017]

Quality Master Program

American chamber of commerce in Egypt and Future university

[ 2017 ]

Certified In Production & Inventory Management (CPIM)

Barcelona, Spain

[ 2018 ]

Accelerated leadership program for talents

Immersion 1

Singapore

[ 2019 ]

Accelerated leadership program for talents

Immersion 2

Rome, Italy

[ 2019 ]

Accelerated leadership program for talents

Final Immersion

Language skills: Indicate competence on a scale of 1 to 5 (1 - excellent; 5 - basic)

Language

Reading

Speaking

Writing

Arabic

1

1

1

English

1

1

1

French

3

3

3

German

3

3

3

Hobbies:

Running, swimming

cycling

Travelling, listening to music.

Competences:

Having good sense of quality management trying to establish an effective relationship gaining trust and respect of others.

Having a very solid background about the regulatory requirements of Health Authorities.

Having the ability to multi task and use all the functional and technical knowledge and skills to perform my role

Takes responsibility for own actions and understands consequences of success or failure.

Pushes self and others for results

Fully supports and implements decisions, strive to deliver ahead of schedule & does not give up, especially in the face of adversity.

Commitment to Quality in the assigned jobs

Shows a strong sense of urgency, works well autonomously, does not introduce complexity & alert others to potential risks & opportunities.

Excellent verbal and written communication / computer skills.

Excellent problem solving and decision making skills. Skilled at conflict resolution /negotiation.

Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas.

Certifications:

Leading at the front line.

Dynamic people management.

Self-directed teams.

Certified trainer.

Communication skills.

Time management skills.

Presentation skills.

Negotiation skills.

Leadership skills.

Lead auditor-training course.

Team building.

Trainings

Summer training

[ Date from - Date to ]

Company

Egypt Otsuka Pharmaceutical Company

[ 2000 ]

Microbiological & Quality Control department

Sedico Pharmaceutical Company [ 2001]

Quality control and Production department

Novartis [ 2001]

Production department

Novartis [ 2002]

Quality control

GSK [2002]

Production department

Novartis [ 2003]

Quality control

Bio Data:

Date of Birth : March 29, 1981 Place of Birth : Giza, Egypt

Material Status : Divorced & having two kids, a daughter and a son.

Mobile phone : +417********

Swiss residence : Holding a B Permit

Email : ***.********@*****.***

LinkedIn Profile : https://www.linkedin.com/in/ola-adel-20300122/

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