Quality Compliance Senior Associate

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

The Quality Compliance Senior Associate will join the Quality Assurance Compliance (QAC) team to support the Annual Product Quality Review (APQR)/Yearly Biological Product Report (YBPR) programs associated with the lifecycle of the drug substance/drug substance intermediate products manufactured at the Pfizer Global Supply (PGS) site in Andover, MA. This role is responsible for independently coordinating and supporting APQR/YBPR activities across all responsible functional areas on site, as well as supporting process improvement activities in collaboration with site and network personnel. Also, as a member of Quality Assurance Compliance, the candidate will be responsible for providing support for board of health inspections and participating in activities in support of regulatory submissions, such as data verification.

How You Will Achieve It

• Support the APQR and/or YBPR process for multiple products, ensuring authoring and review occurs within required timelines
• Support APQR program activities as needed, such as updating the annual schedule, creating bound copies of completed APQRs
• Support the authoring of the APQR Site Summary Report as needed
• Perform any necessary data verification for the YBPR
• Maintain the Quality Assurance Compliance SharePoint page for APQR/YBPR content, maintain APQR/YBPR training materials and support new authors and reviewers in learning about the APQR/YBPR process
• Participate in improvement activities for APQR/YBPR
• Develop relationships and collaborate with other APQR/YBPR colleagues in the Pfizer network to share best practices and look for opportunities for consistency across sites as applicable
• Support activities associated with regulatory submissions, including coordination of query response activities with various functional areas; performing QA data verifications activities as needed
• Participate in the newly launching compliance culture team and support projects, as needed
• Support board of health inspections, remote and on site, as needed

QualificationsMust-Have

• Bachelor's Degree with 4+ years of relevant experience in a regulated GMP environment OR Master's Degree with 2+ years of experience in a regulated GMP environment
• Proficient knowledge of QA compliance
• Knowledge of GMP regulations/guidance (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7)
• A team player with excellent interpersonal, organizational, and communications skills (verbal and written)
• Must be able to handle a diverse and dynamic workload
• Must be self-motivated, engaged and able to perform moderately complex tasks independently; performs routine assignments independently and recognizes when management involvement is necessary
• Strong problem-solving skills

Nice-to-Have

• Pharmaceutical experience preferred
• A broad understanding of APQR
• Experience supporting board of health inspections
• Experience with systems such as Trackwise and LabWare LIMS
• Experience maintaining and updating content on SharePoint

PHYSICAL/MENTAL REQUIREMENTS

• This position will spend significant time in an office type setting as well as attending cross functional meetings.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Typically, a standard Monday through Friday work schedule, primarily work from home during current pandemic with potential to transition to office setting, little to no travel required

  

Other Job Details:

• Last Day to Apply: 15 DECEMBER 2021
• Eligible for Relocation Assistance: YES

#LI-PFE

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.

Quality Assurance and Control