Andover Liquid Dose Manufacturing Compliance Specialist
South San Francisco, CA
Job posting number: #7117762 (Ref:4873553 )
Posted: December 9, 2022
Application Deadline: Open Until Filled
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 Andover Liquid Dosage Manufacturing (AN-LDM) Compliance Specialist role will support the oversight of the compliance program and its associated elements for Pfizer’s state-of-the-art large molecule (mAb, Vaccines, RNA) early-stage clinical drug product manufacturing facility. This dynamic role is meant to grow a quality/science/technology-minded individual focused on ensuring alignment and adherence to changing internal and external quality and regulatory standards.
This role ensures a strong compliance culture and maintains processes to drive high data integrity, quality, and compliance standards. Additionally, the Compliance Specialist will have primary responsibility for supporting audits and implementing continuous quality improvement initiatives.
The Compliance Specialist will support GMP documentation alignment with changing Regulatory requirements across the Pfizer Pharmaceutical Science organization. This role will emphasize strong cross-functional interactions and a close working relationship with the groups in the Clinical Manufacturing Organization and the broader Pfizer Pharmaceutical Science organization.
The Compliance Specialist will interact with clinical operations, technology transfer, quality, analytical labs and engineering/validation groups. The Compliance Specialist may also interact with external boards of health agencies.
How You Will Achieve It
Lead cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer's investigational drug product portfolio.
Provide input supporting revisions to Pfizer Quality Standards (PQSs) and complete gap assessments against established standards to ensure alignment across Clinical Manufacturing Organization and the broader Pfizer Pharmaceutical Science organization.
Support compliance-related metrics, communication and/or presentation of compliance status and progress toward meeting quality commitments.
Support Continuous Improvement initiatives to grow a compliance mindset in the Clinical Manufacturing Organization
Support Liquid Dose Manufacturing at Compliance Forums and support Quality leadership efforts and initiatives.
Support audit and compliance strategy implementation efforts, including inspection readiness, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
Support Investigations, Change Management, CAPAs and Effectiveness Checks, as needed, to ensure proper compliance assessment and alignment
Support compliance-related tasks such as facility certification, quality risk management, risk review etc.
Master’s degree with 1 year of experience, bachelor's degree with 3 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 a matrix environment
Ability to flex and quickly adapt to changing environments and competing priorities
Experience in Quality, Operations and Engineering experience is desired
Experience participating in audits
Experience in continuous improvement or regulatory
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. Flexible colleagues are assigned a Pfizer site within a commutable distance where they work about 2-3 days weekly to connect and innovate with their team face-to-face. However, they also benefit from being able to work offsite regularly when it makes business sense to do so
Relocation assistance may be available based on business needs and/or 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.