Clinical Compliance Lead

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

Pfizer's Durham Clinical Manufacturing Facility (DCMF) is helping Pfizer to lead the health care industry in the rapidly expanding field of AAV gene therapy and biotechnology. We are working to bring new treatments into the clinic with the promise of changing patient's lives. The newly constructed DCMF partners with our Process Development teams to manufacture early clinical stage (Ph1/2) cGMP material, producing both drug substance and drug product. The facility is located near the intersection of Interstate 40 and 540.

How You Will Achieve It

The Clinical Compliance Lead is responsible for ensuring a strong compliance culture and maintaining processes to drive high standards of data integrity, quality and compliance. The Clinical Compliance Lead provides oversight of the compliance program and its associated elements with focus on ensuring alignment with internal and external quality and regulatory standards. Additionally, the Clinical Compliance Lead will have primary responsibility for supporting audits and the implementation of quality initiatives.

• Lead cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer's clinical portfolio.
• Manages compliance related metrics, communication and/or presentation of compliance status and progress toward meeting commitments.
• Provide input supporting revisions to Pfizer Quality Standards (PQSs) and complete gap assessments against established standards.
• Represent Durham Clinical Manufacturing at Compliance Forums and support Quality leadership efforts and initiatives.
• Partner with Validation team to develop and implement instrument and equipment validation lifecycle processes that incorporate regulatory guidance and Pfizer compliance expectations.
• Lead audit and compliance strategy implementation efforts, including inspection readiness, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
• Manages compliance related tasks such as facility access reviews.

Qualifications

Must-Have

• Master's degree with 3 years of experience, Bachelors degree with 5 years of experience, or Associates degree with 7 years of experience in a scientific or engineering discipline in a cGMP manufacturing environment.
• Strong experience with biotechnology processes
• Strong attention to detail, along with excellent verbal and written communication skills.
• Strong decision-making skills, routinely demonstrated in highly complex environments.
• Able to work with cross-functional areas such as quality, manufacturing, and engineering in matrix environment.
• Ability to flex and quickly adapt to changing environment and competing priorities.

Nice-to-Have

• Experience in a Quality role preferred
• Experience participating in audits
• Experience with cell and gene therapy clinical manufacturing.

PHYSICAL/MENTAL REQUIREMENTS

Ability to work in a dynamic multi-discipline organizational model

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Off shift coverage, or holiday coverage, though rare, may be required.

Work Location Assignment: Flexible

Relocation assistance may be available based on business needs and/or eligibility.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development

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