FELICIA K. ANGUS

**** ******** ***** **********, ** 27405

336-***-**** (Cell) 336-***-**** (Office) Email: acon1r@r.postjobfree.com

KNOWLEDGE AND ABILITY

I am a result oriented quality professional with over 20 years of pharmaceutical experience in the clinical, solid dosage, API,

sterile and biological industries and over 5 years of leadership experience. I have a solid background in executing and

monitoring compliance to FDA, EMA, DEA, Canadian, Japanese, Swedish, and ICH and 21CFR820 regulatory requirements

and company SOPs.

ACCOMPLISHMENTS

As the Supplier Relations Team

leader, I lead continuous improvement to the supply of products by negotiating adequate capacity and supply of product

to meet business requirements, aligned with supply and quality agreements.

Manage/deliver cost reduction/avoidance as it relates to the commercial QA budget by setting clear performance targets

and a well defined "playing field" with corresponding personal accountability between NAHUS QA and other Novartis

partners.

As a Project Manager, I demonstrated a proven track record of rapport building, problem solving and excellent

management skills among the Client, external consultants and strategic business partners. Under my direction, our

Validant consultants (12 consultants) have successfully ensured batches have been released to the market.

As the Sr.

Associate, I developed the Internal Audit Training Program and served as the Training Coordinator for Internal Audits.

As the Lead for communications on the Diversity and Inclusion Council, I have coordinated open house for the

employee resource groups (ERG), international food festival and other activities. I have also represented the Novartis

Animal Health Greensboro Team at a number of Diversity and Inclusion community functions.

As a Senior Advisor,

I implemented a process to manage the 3 parties more efficiently by implementing a structured desktop assessment

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and work instructions for the entire team. Oversaw the global third party management program and vendor complaint

program for R&D.

As Quality Manager, I hosted FDA inspections, audits and communicated with regulatory agencies and customers

as needed to ensure compliance and resolve issues, ensured warning letter was lifted by implementing quality systems.

Interacted with the FDA concerning regulatory commitments pertaining to warning letter as a result the warning letter

was removed and the quality systems are still utilized in 2014.

Developed annual audit schedules; provide auditing, risk assessment, and project organization, an integrated training

program for GMP personnel. Periodically assessed training effectiveness and planning support to ensure compliance

which assisted with the removal of the warning letter and effectively ensured Danchem adequately and promptly

corrected the citing’s of the warning letter issued March 2005.

Implemented a GMP Training Program and compliant GMP Quality Systems.

Instilled a quality culture among the GMP Specialist, GMP Operators and Manufacturing Managers (40 employees) by

promoting awareness of quality assurance issues that impact their realm of responsibility to ensure safety, efficacy, and

purity of the API manufactured and commercialized. I served as a strong bonding agent with my team and management

at all levels including FDA.

PHARMACEUTICAL EXPERIENCE

ELANCO (FORMALLY NOVARTIS), GREENSBORO, NC NOVEMBER 2012 CURRENT

QA MANAGER/SUPPLIER RELATIONSHIP TEAM LEAD (SRT)

Manage performance, monitor and provide regular updates on regional manufacturing strategy to complement

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regional and global production needs.

Manage team deliverable outputs : dashboards, KPIs, reports at SRT and Governance level (T2, T3)

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Comprehensive Change Management for 3rd party support (change control from initiation through final closure)

Oversee contract manufacturers, providing guidance from a QA perspective, to ensure compliance with Novartis

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quality manual and regulatory authority requirements/cGMP for such activities as: cleaning, equipment, method

validations, process optimization, scale up and registration batch manufacture, effectiveness of corrective and

preventive actions (CAPA) for investigations, deviations, the review and approval of master and executed batch

records, validation protocols and final reports for process and analytical activities, investigation reports, stability

commitments, Manufacturing Changes and Stability Report (MCSR), Annual Product Review (APR) and Chemistry,

Manufacturing and Control document (CMC) submissions, and complaint handling.

Evaluate trends periodically for key process indicators, such as customer complaints, deviations, out of specification

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(OOS) investigations, stability, CAPA, etc. to ensure systems are functioning in compliance with Novartis and

regulatory authority requirements/cGMP; implement appropriate actions where necessary.

Manage information flow with contractors for product defect complaint investigations, ensuring complaints are

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thoroughly investigated and reported appropriately and timely as required by the type of investigation, Novartis

procedures and regulatory authority requirements/ cGMP.

Maintain and/or establish Quality Agreements with contractors to ensure adherence to Novartis and regulatory

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authority requirements/cGMP.

Evaluate new or existing contractors, assessing compliance with Novartis and regulatory authority requirements, to

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support development, testing, commercial manufacture, packaging and/or storage of new or existing products.

Support projects from a QA perspective for new or existing products and/or promotional activities.

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Served on the Team Health Committee

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VALIDANT, SAN FRANCISCO (CONSULTING)

APRIL 2012 NOVEMBER 2012

LEAD CONSULTANT

• Served as project manager between clients, line management and internal resources which included planning,

directing schedules and providing recommendations to challenging processes to ensure compliance.

• Responsible for all aspects of the development/implementation of projects and programs involving department or

cross functional teams focused on the delivery of a product or program from the design process through a finished

state for internal/external customers.

• Takes projects from original concept through final implementation.

• Oversaw/coordinated all aspects of batch review project by developing detailed work plans, schedules, project

estimates, resource plans, and status reports.

• Conducted project meetings, served as a single point of contact for projects and responsible for project deliverables.

Ensure Validant consultants are appropriately trained when they join the group and thereafter on an ongoing basis.

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BIOGEN IDEC, Research Triangle Park, NC (Commercial) July 2011 April 2012

Sr. Associate III, Drug Compliance

• Led Biogen Idec internal audits across Biogen Idec sites, provide written reports of observations.

• Performed routine monitoring activities to ensure compliance to internal procedures and GMP regulations.

• Facilitated maintenance of internal databases including metrics and trending of audit results.

• Worked with operational teams within PO&T to ensure timely completion of Audit responses and CAPA closures.

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F. ANGUS – 3

GLAXOSMITHKLINE, Research Triangle Park, NC (Research & Development) August 2007 July 2011

Senior Advisor

• Performed initial and reassessments of third parties; lead external audits.

• Assessed and qualified third party suppliers via supplier audits (on site and desktop).

• Responsible for the third party approval process for materials which included oversee of change controls and quality

investigations related to material issues.

• Supported projects for new materials and suppliers to pharmaceutical development.

• Monitored third party re assessment dates to ensure on time completion.

• Ensured global compliance with relevant third party management procedures, processes and policies.

• Verified and close out internal and external CAPAs according to agreed timelines.

• Assisted in department and interdepartmental problem solving and project activities.

• Trained staff on routine procedures and basic GXP regulations.

ABRAXIS BIOSCIENCE, Durham, NC (Biopharmaceutical Injectable) Mar 2007 August 2007

Clinical Quality Assurance Auditor

• Planned and conducted internal audits of Abraxis quality systems to ensure compliance with Company SOP’s,

GCP’s, and other applicable regulatory requirements. Prepare audit reports and agree on responses / CAPAs.

• Audited clinical study reports, regulatory submission documents (i.e., ISE, ISS, and investigator brochures),

CRO/vendor audits and evaluations, master files and clinical systems audits, such as data management and safety

reporting systems in addition to clinical site audits. Identified critical risks and agree on risk mitigation plans.

• Reviewed (QC) internal documentation (study protocols, for compliance to Company SOP’s, GCP’s, and other

applicable regulatory requirements.

• Assisted in the preparation for international and domestic regulatory agency inspections, and external consultant

audits.

• Developed, implemented and revised Quality Assurance SOPs.

• Reviewed quality related documentation in support of drug product shipments.

DANCHEM TECHNOLOGIES, Danville, VA (API Manufacturer) Sept 2005 August 2007

Site GMP QA Manager

Performed all quality related tasks such as: new hire GMP training, audits, issue Certificates of Analysis (CoA).

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Performed final review and approval of: final product testing, batch records, environmental monitoring, change control,

non conformances, investigations and validations. Managed the GMP management system to ensure conformance

with the FDA regulations (Q7A).

Provided leadership and direction regarding the need for changes in equipment, operations, practices, or procedures

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to ensure compliance with GMP regulations and policies. Inform and update executive management personnel with

regard to existing and potential GMP issues and provide strategic direction or initiatives to achieve organizational

effectiveness.

Monitoring of day to day manufacturing operations to assure that the production processes are in compliance with and

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followed as per the FDA guidelines, written Operating procedures and company policies.

Ensure that the raw materials used in the production are from the qualified/approved vendors, meet internal quality

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testing specifications and not counterfeit.

Ensure that the API to be commercialized complies with the quality testing specifications and meet standards for

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safety and efficacy for the consumers.

Ensure that all departments are in compliance with cGMPs, FDA guidelines, SOPs and company policy.

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WYETH, Sanford, NC (Vaccine Manufacturer) February 2001–September 2005

Corporate GMP Audit Manager

• Managed Domestic and International R&D and commercial audits of third party suppliers and internal compliance

which included external audits of laboratories, contract manufacturers (vaccines, solid dosage, etc.), API

manufacturers, raw material suppliers, packaging components suppliers, and warehouses / distributors, CAPAs.

• Prepared and issued audit reports outlining good practices and business risk areas to senior management.

• Provided above site support for regulatory inspections.

• Performed gap assessments of new and revised policies with respect to global procedures.

Senior QA Analyst

Trained QA personnel on quality related procedures and processes.

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•Labeled and released raw materials, intermediate and packaging components for manufacturing use.

• Reviewed and approved Master Production Records and executed batch records for final release.

•Performed investigations for manufacturing/laboratory discrepancies, deviations and consumer complaints.

•Monitored Material Discrepancy Notices for timely dispositions, appropriate corrective actions, and rapid closure.

•Conducted internal cGMPs audits of production facilities, laboratories, quality systems and documentation.

•Managed CAPAs involving suppliers, material specifications, storage requirements, and material acceptance.

APPLIED ANALYTICAL INDUSTRIES (AAI), RTP, NC December 1998 February 2001

Technical Specialist QA/Regulatory Group

Performed training for quality manufacturing employees.

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• Supervised quality/process improvements through facilitating team based improvement initiatives.

•Evaluated, analyzed and reported product and process performance and assured corrective actions/commitments

were implemented in a timely manner.

•Performed process start up inspections, releasing equipment, verified dispensed materials, AQL sampling and

testing, disposition incoming materials/components, quality database maintenance and quality audits of

pharmaceutical production processes and laboratory operations; Approved new /revised specifications.

•Approved master manufacturing/packaging records, process validation, cleaning validation protocols and reports,

batch records, process validation. training records and SOPs related to production, quality control, NDA and ANDA

validations (which include CMC/manufacturing submission reports), technical transfer reports, analytical methods

validation reports, process validation, laboratory investigations, manufacturing deviations and change control reports

to ensure internal standards and cGMP guidelines were met.

Clinical Coordinator QA/Compliance

Audited AAI’s policies/procedures and made recommendations to ensure compliance.

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•Audited clinical study reports, regulatory submission documents (i.e., ISE, ISS, and investigator brochures),

CRO/vendor audits and evaluations, master files and clinical systems audits and monitored various aspects of

compliance with cGMPs, cGCP, and cGLP and Bioanalytical studies.

• Performed/facilitated time efficient pre study initiation process and oriented site personnel to study

protocol/procedures and managed study site activities.

PROCTER & GAMBLE, Brown Summit, NC (Health & Beauty Manufacturer) May 1992 December 1998

Team Leader

•Supervised 3 5 lab analysts, ordered materials, and provided technical support, communicated with lab management

to define priorities.

Conducted laboratory audits per GMP, OHSA and FDA regulations.

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Managed documentation for validations and stability activities.

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Approved/Rejected intermediates and raw materials.

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F. ANGUS – 5

EDUCATION

B.S. – CHEMISTRY, 1996

North Carolina Agricultural & Technical State University

PROFESSIONAL ORGANIZATIONS

American Society for Quality American Chemical Society (Student Body President 1995

1996)

Regulatory Affairs Professional Society Greensboro Jaycees (VP of Membership, VP of Internal Affairs)

R.I.E.L Toastmasters (President & Public Relations Drifters Greensboro Chapter

VP)

National Association of Professional Women Upward Bound Trio Program (Chemistry Teacher)

VOLUNTEER ACTIVITIES

Family Fun Festival Planning Committee (2013)

Green Garden Project Planning committee (2011)

Holiday Parade Balloon/volunteer coordinator (2011 2013)

Wyndham Golf Tournament Hospitality Chairman for Hole 17 (2011 Present)

Hugh Obrien Youth Leadership Retreat Facilitator (2011, 2012, 2013)

Northeast Youth Association (2011 2013)

Board Member Fundraising/Volunteer coordination

Host Annual Spaghetti Dinner for Northeast Youth Football team to teach good sportsmanship and etiquette.

United Caribbean Association President (1996 2011)

Taste Carolina Wine Festival Planning committee (2011)

Garrets Grove UMC Teach Character and values to the youth (2008 Present)

Cornerstone Charter Academy (2012 Present)

Provide Character Education to different classes on Wednesdays of every week school is being held.

Cornerstone Charter Athletic Program Board Member Fundraising/Volunteer Coordination

Commission on the Status of Women CSW (2014)

Commissioner for the City of Greensboro (CSW)

Chairman of the Women and Equality Sub Committee

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