Regulatory Quality Assurance Gmp Audit Manager

ROLE SUMMARY

ROLE RESPONSIBILITIES

As assigned, independently lead or participate in GMP/GDP audits and assessments of contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacture, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. Assess if the auditee is executing operations in compliance with cGMP/GDP requirements and guidelines, Pfizer Quality Standards and Quality Agreement requirements and Standard Operating Procedures.

Assess whether employees are being properly trained for their responsibilities, as well as the adequacy of the facilities and equipment used for manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products. Communicate relevant quality and business information to the, contract manufacturer, supplier or GMP/GDP service provider audited, in an effort to maintain and enhance the relationship between the auditee and Pfizer. Interpret regulatory and business challenges and best practices, report risks or weaknesses that could lead to cGMP/GDP compliance issues, and recommend improvements or solutions. Lead or participate in GMP audits at contract manufacturers, suppliers and GMP/GDP service providers. May participate in GMP audits of Pfizer facilities. Responsibilities for these activities include but are not limited to:

- Lead negotiations with auditees to schedule audits
- Lead audit preparation activities including gathering of and review of auditee’ relevant quality and performance metrics to determine risk-based audit scope
- Lead the audit execution, or actively participate in the audit execution as directed by the lead auditor
- Lead the preparation of audit reports - Lead the review and evaluate the adequacy of the auditee response to audit findings
- Perform audit follow-up activities as required or as directed by leadership

Develop cross functional collaborative relationships to facilitate engagement, team building, best practice sharing, risk-based analysis, critical thinking and innovative problem solving. Participate in department wide initiatives to advance the business strategy of the GMP audit function.

Required Qualifications:
Bachelor’s Degree in pharmaceutical sciences or equivalent required.

Minimum 5 years of progressive, challenging experience in the biopharmaceutical industry required, inclusive of quality control / assurance, manufacturing and GMP auditing (may include Product Development).

Proven knowledge and experience in GMP auditing of at least 3 technology platforms and areas of specialization such as small molecules, biologics, medical device combination products, active pharmaceutical ingredients, aseptic operations, non-aseptic operations, laboratory operations (chemistry, microbiology, specialized), advanced therapies, computerized systems, software as medical device, good distribution practices, and Pfizer country offices.

Preferred Qualifications: Recognized audit certification (e.g., ASQ) is desirable.

Experience in shop floor quality assurance is desirable. BoH / Notified Body experience is desirable.

Knowledge of Medical Device Regulations is desirable.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Ability to travel up to 40% of the time, including domestic and international traveling.

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Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Quality Assurance and Control

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