Quality Systems Change Control Manager

Quality Systems Manager

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.

You will be a member of Pfizer's dedicated and highly effective Quality Systems Team. As the manager of Change Control, you will oversee the process, compliance, and performance of the Site's Change Control program, including regulatory change management.

The manager plays a key role in setting the strategic direction for process improvements and the evolution of contemporary change control practices to support manufacturing of biotherapeutic drug substance at the PGS Andover, MA site. The Manager is integral in supporting the Site's Quality culture through oversight of Site Change Control program.

It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

Collaborates with key internal and external partners to ensure the Site's needs are met with corporate standards and enterprise system solutions (relative to change control).

Leads a team of approximately five colleagues, focusing on colleague development, forecasting and level loading of work assignments, and cross training to meet the commitments of the Site

Manage the interdependencies between site change management process and regulatory change management system

Provide support to project teams on change control strategy and related compliance issues to ensure compliance with company policies and government regulations

Review and approve investigations, commitments, and procedures as they relate to quality systems

Fosters a culture of continuous improvement.

Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.

Demonstrated management experience, either through direct people leadership or significant project management experience.

Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.

A team player with strong interpersonal, organizational, and communications skills are a must. Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.

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

Typically, a standard Monday through Friday work schedule, hybrid work schedule between home and office

May require support for site as needed beyond core business hours.

Little to no travel required.

Work Location Assignment: Hybrid

Last Date to Apply for Job: April 10, 2023

Referral Bonus Eligibility: YES

Eligible for Relocation Package: YES

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.