Pfizer QA Manager in Andover, Massachusetts

ROLE SUMMARY

Candidate is responsible for providing Quality Assurance leadership to GMP Manufacturing and Testing Operations (site-based and vendor) relative to the disposition of clinical trial material. This may include review of batch records, investigations, SOPs, test methods and change controls. Serves as a Quality representative and single point of contact on Pre and/or Post Proof-of-Concept product teams.

This position requires a solid understanding of quality systems as they relate to the manufacturing, testing and packaging of biologic cell banking, API/biological drug substance and sterile drug product. Experience with vaccine, cell-based therapies and gene-based therapies are a plus.

The candidate shall possess experience in quality operations oversight to clinical materials at different phases of the product lifecycle (i.e. IND through BLA). This includes the ability to navigate through complex supply channels across the globe and the ability to identify and manage different levels of risk in support of good quality judgment against global regulations. This may include advising the business on moderately complex quality issues.

Minimal business travel may be required to other Pfizer locations as well as to contractors/suppliers/external laboratories used by Pfizer.

This position does not include the management of direct reports.

This position is based at the Andover, MA Pfizer location.

ROLE RESPONSIBILITIES

  • Represent Quality on clinical product teams. This includes representation on early phase Research and Development Pharmaceutical Science Project Teams (PSPT) or later phase Co-Development Teams (CDT)

  • Ability to lead global quality sub team meetings for a particular project(s)

  • Ability to negotiate and author quality agreements

  • Ability to lead a small quality team participating in the BLA regulatory filing data audit activities

  • Support internal and external GMP audits and inspections which includes, planning / logistical support, interactions with inspectors / auditors,. scribe functions, backroom and communication support.

  • Support programs in combination biologic/device platforms. Provide compliance oversight to Medical Device regulations and QSRs.

  • Independently provide quality leadership and oversight activities to project teams and day-to-day cGMP manufacturing and testing for clinical trial material

  • Ability to execute moderately complex tasks with minimal coaching

  • Ability to present to peers/management locally or electronically

  • Participate on technology transfer teams

  • Perform disposition of clinical trial materials

  • Review and/or approve various GMP documents including procedures, batch records, protocols, reports, investigations, change controls, etc.

  • Provide review of equipment/instrument validation documentation, change control and related calibration documentation, to various GMP facility and testing operations including drug substance and drug product facilities.

  • May have experience with utilizing quality risk management principles

  • Advise on policies and procedures. Provide leadership to the interpretation of GMPs for the functional areas

  • Represent quality on right first time and control strategy discussions. Contribute to late phase BLA strategy, ICH stability strategy, etc.

  • Lead and/or participate on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.

  • Interpret and disseminate information about current industry and regulatory trends; advise customer groups on current industry standards and modifications to current systems required to meet these standards.

  • Provide formal/informal mentoring of Quality Operations colleagues, as needed

  • QUALIFICATIONS Educational Requirements BS/MS - minimum of 10-12 years technical / scientific / Biopharmaceutical experience. PhD - minimum 7 years technical / scientific / pharmaceutical experience relevant work experience. Based upon education, candidate should possess a minimum of 7-12 years of Biopharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes. In addition, extensive knowledge of global GMP and regulatory requirements as related to the drug development process is required. Experience in Quality Assurance possessing strong quality culture is desirable. Team player with strong interpersonal, organizational, and communications skills are a must. Additionally, candidate must be self-motivated, engaged and able to perform moderately complex tasks independently. . Conduct training in compliance and regulations.

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.

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.

  • Last Date to Apply for Job: August 23, 2018

  • Eligible for Employee Referral Bonus

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.