QA Manager, Raw Materials

Andover, Massachusetts
Jun 24, 2022
Required Education
Bachelors Degree
Position Type
Full time
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

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

  • Represents QA onsite teamswith minimal supervision.
  • Leads quality discussion and uses breadth of knowledge to contribute to strategies and decisions.
  • Will be responsible for collaborating with both Quality Control and Operations, STS, Pharm Sci and other stakeholders as applicable.
  • Influences quality strategy for all aspects of raw materials and supplier management from a QA perspective.
  • Acts as back-up for QA Sr. Manager as applicable
  • Independently handle complex investigations in cross-functional work areas.
  • Collaborate/independently engage with a wide range of co-workers, customers and management within PGS to gather the input and background knowledge needed to complete assignments.
  • Anticipate issues and escalate to appropriate management attention immediately.
  • Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
  • Reviews and approves routine to complex investigations, providing sound quality assurance judgment to ensure product quality.
  • Exercises judgment in resolving moderate to complex quality issues.
  • Plans and executes work independently and consults with supervisor as needed.
  • Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs. Seeks out regulatory guidance for new product introduction.
  • Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact.
  • Leads the QA Raw Materials team and supports daily activities.
  • Active participant/lead for M1s/M2s; promoting and leading adherence to the DMAIC process. Champion for implementation of sound preventative actions, leveraging the Pfizer Human Performance tools.
  • Coach/mentor/train other QA colleagues that will be hired for QA Raw Materials

  • Bachelor's Degree
  • 5+ years experience of Management, 3 years QA Experience
  • Working knowledge of current Good Manufacturing Practices {cGMP} for a pharmaceutical industry
  • Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced
  • Strong collaboration, relationship management, and interpersonal skills
  • Strong people management experience
  • Excellent written and oral communication skills
  • Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent

  • Master's degree

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.

Quality Assurance and Control