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Manager, Quality Assurance

Company: Pfizer
Location: Andover
Posted on: November 22, 2021

Job Description:

Why Patients Need YouEverything 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 AchieveYou will be a member of Pfizer's dedicated and highly effective quality assurance team. As the Quality Manager for Building A Suite A/B, you will work as a partner with Operations, QC, Engineering, Maintenance and Utilities (EMU), Planning and Site Technical Services (STS). You will be accountable for all activities required to disposition product and ensure overall compliance of all processes included in the Suite A/B Asset. You will ensure 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. Your expertise in Quality Assurance and Leadership will make Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It

  • Lead 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, Corrective Action/Preventative Action (CAPAs), Change Controls.
  • Partner 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.
  • Participate in the recruitment, selection, promotion, termination, and performance management of QA employees.
  • Partner with the Asset Team (Operations, Engineering, Technical Services and Supply Chain) to provide feedback on performance of non-Quality personnel.
  • Partner 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 Operational Excellence/Continuous Improvement methodology to drive performance.QualificationsMust-Have
    • Bachelor's Degree required
    • 10+ years of relevant experience within the pharmaceutical or medical device industry
    • 5+ years of direct management/supervision experience
    • 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 impactNice-to-Have
      • Chemistry, Engineering, Biology, Manufacturing Management field of study preferred
      • Experience in QA and/or Manufacturing and/QC, experience dealing with Regulatory compliance
      • Experience in problem solving, process improvement, negotiationsPhysical/Mental Requirements
        • Ability to gown and enter the manufacturing Suite as neededNon-Standard Work Schedule, Travel, or Environment Requirements
          • This role is primarily standard day shift, Monday - Friday. May be required to work outside of standard work hours to support manufacturing as quality issues ariseOther Job Details:
            • Eligible for Relocation Assistance: YES #LI-PFEPfizer 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 ActPfizer 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 EligibilityPfizer 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#LI-PFE

Keywords: Pfizer, Boston , Manager, Quality Assurance, Executive , Andover, Massachusetts

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