Andover Liquid Dose Manufacturing Compliance Specialist

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.

The position is located in Andover, MA.

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.

Qualifications

Must-Have

• 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

Nice-to-Have

• Experience in Quality, Operations and Engineering experience is desired

• Experience participating in audits

• Experience in continuous improvement or regulatory

PHYSICAL/MENTAL REQUIREMENTS

• Experience in Quality, Operations and Engineering experience is desired

• Experience participating in audits

• Experience in continuous improvement or regulatory

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

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.