QA 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 assurance team. You will be part of the Pfizer Global Biotherapeutics Quality Organization that provides oversight to Pfizer’s clinical pipeline.

This senior role is responsible for providing experienced, quality assurance oversight to all aspects of validation, calibration and maintenance of equipment, utilities and facility infrastructure for our GMP Cell Banking, Drug Substance, Drug Product and supporting Laboratories.

This role will provide sound quality direction and strategy regarding change control use within these support areas.

You will provide guidance, Quality lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the Department. This may include providing quality strategies for new/novel equipment technologies, facility construction or enhancements.

You will build relationships within the business and quality at all levels and be able to communicate and present effectively(orally and written).

On-site support is required for this role but you will have flexibility to work remotely as well.

This role does not have direct reports but training and mentoring more junior colleagues will be required as needed.

How You Will Achieve It

• Act as a primary quality point-of-contact for our business lines as it relates to equipment and facilities support.
• Ability to make quality decisions to resolve complex issues with minimal assistance from management.
• Ability to plan and forecast work for projects as needed.
• Ensure the validated state, calibration and maintenance of equipment, utilities and facilities supporting manufacturing and laboratories aligns with procedures, corporate policies and regulatory requirements.
• Review and approve change controls including assessment of impact to validation and supporting operations and laboratories maintaining a validated state.
• Review related validation documentation such as specifications, protocols, testing documents, summary reports, data integrity assessments and validation plans.
• Review and approve equipment and facility calibration documentation as needed.
• Review and approve role-related investigations, commitments and procedures.
• Responsible for knowing, understanding and acting in accordance with Pfizer’s values.
• Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role as needed.
• Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes and people.

• Bachelor's Degree in Biological Sciences and Engineering
• 8+ years' of relevant experience
• Experience in equipment, utilities and facilities operation including thorough understanding of validation lifecycle including inclusive of cleaning validation.
• Thorough understanding of change control quality system principles
• Understanding and experience with Data Integrity and ALCOA principles
• Have knowledge and experience in computer system validation in support of local automation (e.g. manufacturing control systems such as Delta V and SCADA, laboratory systems).
• Understanding of global regulations as it pertains to equipment, utilities and facilities supporting manufacturing and testing.
• Ability to manage multiple projects and priorities on a daily basis with minimal supervision.
• Proactive approach and strong critical thinking skills.
• Strong collaboration, relationship management, and interpersonal skills. Candidate must have a positive outlook, be self-motivated and effectively work independently an within a team setting
• Excellent written and verbal communication.
• Advanced computer skills in MS Office applications and experience using enterprise systems (QTS/eQMS/EAMS, etc).

• Master's degree in Biological Sciences or engineering
• Previous experience as an automation engineer using manufacturing control systems(MCS).
• Quality Assurance experience possessing strong quality culture is desirable.
• Ideal candidate would have Biopharma industry experience

PHYSICAL/MENTAL REQUIREMENTS

• Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
• Mental agility to reprioritize work frequently based upon business and quality needs in a fast-paced environment.
• Ability to independently problem solve and make recommendations for solutions.
• Role is primarily office-sitting, standing, walking and bending. This may be inclusive of leading/participating in MS Team or WebEx meetings.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• First shift work schedule. Some off hour coverage may be required to meet business needs.

Work Location Assignment:Hybrid

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.