Senior Quality Professional

Evans Oviosun

Greensboro, NC 336-***-****

LinkedIn.com/in/evansoviosun5863 ********@*****.***

Senior Quality Assurance Manager

Supplier Quality Management Risk Assessment and Mitigation Pharmaceutical Manufacturing

Results driven and committed quality assurance manager with over 25 years of industry experience in pharmaceutical manufacturing, supplier management, and regulatory compliance. Expertise in leading quality assurance team through production support and implementation of all quality policies. In-depth knowledge of FDA regulations, ICH guidelines, domestic and global standards. Proven experience in liaising with third party suppliers and conducting test requirements of the project at all stages of process. Ability to identify quality improvement opportunities and execute strategic measures to mitigate risks. Proven track record of performing periodic audits internally and implementing corrective solutions for non-conformances detected during auditing. Excellent communication, interpersonal, and team leadership skills.

Supplier Quality Management

Risk Management

Problem Solving

Quality Systems

Project Management

Regulatory Compliance

Laboratory Management

Quality Analysis

Process Improvement

Auditing

Team Leadership

Change Management

PROFESSIONAL EXPERIENCE

Reynolds American Incorporated, Winston Salem, NC June 2020 – June 2021

Lead Manager – Supplier Quality Assurance

Led a team of Supplier Quality professionals to implement a viable alternative for onsite audit in the wake of the COVID-19 pandemic.

Designed a remote audit framework for evaluating, qualifying and assessment of critical suppliers to ensure ongoing compliance resulting in savings of greater $250,000.

Developed a risk-based tool to identify if an on-site audit or remote audit is appropriate based on risk factors.

Collaborated with Supply Chain, Manufacturing and Quality Control to drive improvements using scorecards, ensuring supplier compliance and drive supplier performance improvement initiatives.

Initiated monthly suppliers risk management review program to identify, mitigate and escalate potential risks as appropriate.

Performed all phases of an audit including planning, execution, documentation and reporting in compliance with regulatory requirements.

Attended local, regional and global Quality Council Meetings and provided updates/progress of identifiable compliance milestones and deliverables.

CATALENT, Morrisville, NC May 2016 – May 2019

Manager – Quality Assurance

Oversaw development and execution of quality systems and ensured policies and procedures were strictly in adherence to industry and regulatory standards.

Evaluated departmental activities to ensure compliance to FDA, EU, and audit requirements. Coordinated multi-faceted processes towards common objectives and regulatory inspections.

Developed process maps for quality assurance benchmarks and collaborated with internal and external stakeholders to implement process improvement strategies.

Managed supplier quality program, led audits, quality testing processes, and recommended corrective action plans to escalate quality of production and compliance with rules and regulations.

Authored and implemented quality agreements and inputs to supply agreements, project/program plans and statement of work.

Conducted customer audit program and addressed queries and feedbacks on a timely basis.

Supported the Data Integrity Remediation Plan (DIRP) initiative including and not limited to the review of data migration, data management, and governance.

Attended local, regional and global Quality Council Meetings and provided updates/progress of identifiable compliance milestones.

Developed and implemented processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards in support of QA manufacturing activities.

Provided subject matter expertise for the review and implementation of validation related procedures and templates to support manufacture of clinical product (Phase 1 through 3). Procedures and templates including URS/FRS/DS development, validation periodic reviews, protocol deviations, equipment/facility/utility qualification requirements.

Reviewed technical and study reports, investigations, study protocols, and reports.

Worked across functionality, representing the quality group on discovery and development teams, line functions and to senior management for awareness and compliance with quality/regulatory requirements.

Developed solutions to complex quality issues and identified, prevented, and/or resolved significant compliance issues.

Led a team of eight quality and technical associates, facilitating subject matter expertise on ongoing basis.

PROCTER AND GAMBLE, Greensboro, NC Jul 2014 – May 2016

Manager, Quality Systems & Compliance

Owned site Quality Systems with responsibility to monitor, continuously improve, and report KPI compliance metrics for deviations, CAPAs, change controls, product release, complaints, LIRs, and identifying emerging trends and potential risk.

Managed audit program against GxP standards, FDA/EMA/ICH requirements, and other regulatory standards ensuring timely resolution of identified issues.

Collaborated with key business partners and cross-functional stakeholders in support of operations, operational excellence, and compliance improvement projects to guide timely and effective decisions.

Supervised quality control initiatives conducted annual product review, managed complaints and internal/external audit programs.

Ensured ongoing alignment and harmonization of policies and procedures between local site and corporate

Managed global approved supplier list (ASL) and supplier audit schedules

Audited supplier quality, performed due diligence evaluations to identify and implement improvement measures for vendors, and ensured compliance with rules and regulations.

Directed site audit readiness and furnished all required inputs for regulatory inspections by FDA, MHRA and ANVISA.

Led internal audit programs and executed strategic solutions to implement remedial solutions. Administered vendor qualification program for third party vendors and suppliers.

Provided technical expertise and presented risk-based solutions to senior site leadership team.

TEVA PHARMACEUTICALS, Greensboro, NC Sep 2012 – Jun 2014

Senior Manager, OTC Global Quality Initiatives

Managed quality assurance initiatives for OTC Americas businesses, and addressed site audit requirements for TEVA GRAS, FDA, MHRA and ANVISA inspections.

Co-hosted regulatory inspections, prepared sites for audit readiness, and guided response plans, including TEVA, FDA, MHRA and ANVISA at the respective North America manufacturing site.

Supervised qualification and validation processes for establishing new facility expansion. Facilitated subject matter expertise in implementing corporate standards and quality systems throughout the company.

Collaborated with CMOs to prepare PGT technical guidance documents for due diligence assessments. Coordinated internal and external audits on a timely basis.

Built teams to identify and execute the required actions to transition existing practices to Teva Corporate Standards and Quality Systems.

Monitored site KPIs and performance, prepared data to communicate potential misses that impact business and recommended remedial plans.

Served as a change catalyst to harmonize procedures, practices, and knowledge of quality and compliance to align with Teva Corporate Standards.

Attended local, regional and global Quality Council Meetings and provided updates/progress on identifiable compliance milestones.

Served as single point of contact and corporate liaison for complex projects driven by compliance needs of each site.

Provided guidance, active participation, and resolution for critical quality issues that impact North America manufacturing sites.

Used industry knowledge and experience to share best practices and influence the site compliance level in a positive manner.

BANNER PHARMACAPS, High Point, NC May 2009 – Sep 2012

Senior Quality Assurance Auditor

Oversaw preparations for regulatory inspections, conducted internal and external audits, and provided guidance to ensure compliance with Federal regulations and approved Banner policies and procedures.

Designed, implemented, and managed Supplier Audit process including but not limited to Supplier Quality performance metrics, scorecards, and routine surveillance systems.

Managed the approved supplier list (ASL) and approved audit schedules.

Collaborated with key business partners to drive adherence to timelines, facilitated resolution for base business projects, supply chain compliance, and import/export issues.

Provided subject matter expertise in GMP, GLP, GCP regulatory requirements, mitigated and escalated issues on an ongoing basis and enterprise compliance risk management.

Implemented risk-based approach to supplier assessments and led mitigations to resolution, providing escalation as appropriate.

Provided training and coaching for employees to follow standard operating procedures on auditing practices.

CONVATEC INC., Greensboro, NC Jan 2006 – May 2009

Compliance Quality Auditor

Designed, implemented and managed Supplier Quality and Purchasing Controls process to meet business, regulatory compliance, and International Standards including CFR Part 820, 210, 211, and ISO 13485 requirements.

Designed, implemented, and managed Supplier Audit process including Supplier Quality performance metrics, scorecards, and routine surveillance systems.

Managed the approved supplier list (ASL) and approved audit schedules.

Supervised internal audits to ensure compliance with FDA/ISO regulations and requirements, coordinated Global QMS audit program, and implemented lean initiatives to eliminate redundancies between global and internal audit programs. Audit travel expenses were reduced by 50%.

Contributed to the recertification of quality management system as required by ISO 13485 and the Canadian Medical Device Regulations.

CONVATEC INC; (Bristol Myers Squibb Company), Greensboro, NC Jun 1997 – Jan 2006

Associate Manager, Quality Assurance

Reported to the Director of Global Quality Management. Led, scheduled, planned, conducted, and reported results of internal, plant, and supplier quality management system audits and assessments including the identification of continuous improvement (CI) opportunities. Reviewed and approved CAPAs for completeness, adequacy of investigations, appropriateness of actions taken or proposed, performed effectiveness verifications and recommended closure. Coordinated and monitored raw materials quality attributes among multiple vendors and supply channels. Managed a staff of seven quality assurance professionals including the resident Microbiologist.

Established and champion in collaboration with senior management team, strategic quality plans aligned with overall business objectives that provided the highest level of product quality and customer satisfaction.

Developed and implemented dock-to-stock inventory system thereby reducing inventory levels for purchased components while building profitable relations with suppliers through continuing improvement initiatives.

Developed and implemented Quality Assurance Manual and Procedures for compliance to FDA 21CFR 820:1997, ISO 13485:2003 and SOR/98-282 Medical Device Regulations: Canada.

Directed testing for all incoming raw materials, components and finished products for compliance to established specifications and regulatory standards.

Contributed to the establishment of the Corporate Supplier Quality System Assessment program (Partners-In-Excellence) through vendor certification resulting in savings of 150K.

Led internal and external audits and validated test methods of critical suppliers resulting in 25% reduction in incoming raw materials nonconformances.

Key driver in customer-led focus for planning and organizing product release in improved output and lead-time reduction.

Managed quality assurance programs by establishing operational techniques and activities aimed at monitoring processes and eliminating causes of unsatisfactory performance at all stages of manufacturing.

Generated monthly status and trend reports to senior management including presentations at Management Reviews

EDUCATION & CREDENTIALS

Master of Science in Chemistry, North Carolina A&T State University, Greensboro, NC

Bachelor of Science in Industrial Chemistry, Western Carolina University, Cullowhee, NC

Certified Quality Auditor (CQA), American Society for Quality (ASQ)

Certified QMS Lead Auditor, RABQSA

TRAINING AND DEVELOPMENT

Project Management – Kepner – Tregoe Project Management

Leader-In-You Training – Bristol Myers Squibb Company

Global Awareness: EU Medical Devices – Regulatory Affairs Professionals Society (RAPS)

AFFILIATIONS

Senior Member, American Society for Quality (ASQ)

Member, American Chemical Society (ACS)

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