Pfizer Quality Assurance Manager in Andover, Massachusetts
Working as a partner with Operations, QC, EMU, Planning and STS the Building A Suite AB Quality Manager is accountable for all activities required to disposition product and ensure overall compliance of all processes included in the Suite A/B Asset. Additionally, is accountable for the assurance that all activities related to processing, and disposition for the product(s) is/are in full compliance with government regulations and internal company standards and values. Strong communications skills are needed to be successful in this role
Leads the efforts of QA personnel responsible for the monitoring, testing, and disposition of the product in compliance with all regulatory requirements, company policies, values, and goals
Responsible for quality record review such as investigations, CAPAs, Change Controls.
Partners with other QA managers to ensure consistency and efficiency within the QA department.
This position requires strong collaboration skills.Working with the network and Prevnar product team to ensure supply of Poly.
Decision maker for compliance and quality issues and documentation such as investigations, protocols, change controls, regulatory filings, etc.
Responsible to the asset for GMP compliance of the Suite AB manufacturing facility as well QA shift support for all assets
Participates in the recruitment, selection, promotion, termination, and performance management of QA employees
Partners with the Asset Team (Operations, Engineering, Technical Services and Supply Chain) to provide feedback on performance of non-Quality personnel.
Partners with the Asset Team for cross-functional management staff to evaluate production process needs, resolve problems and obstacles, provide resources. Reset direction and maximize effective interactions and functioning using IMEX to drive performance
BS or BA degree (Chemistry, Engineering, Biology, Manufacturing Management)
12 -15 years experience in pharma/biopharma industry, 5+ years management experience
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance. Experience in problem solving, process improvement, negotiations and supervision
- Ability to gown and enter the manufacturing Suite as needed
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
24/7 support of manufacturing as quality issues arise
Some travel may be required but expected to be minimal.
Last Date to Apply for Job: 22 May, 2020
Eligible for Employee Referral Bonus
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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