QA Site Compliance Lead

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.

• ROLE SUMMARY

  This position is a member of the Site Quality Leadership Team and will support the Pfizer Andover, MA Quality Compliance department by leading site inspection readiness strategies and managing colleagues for the Quality Compliance activities associated with clinical and/or commercial product. The Senior Manager, Site Compliance Lead will primarily head the QA Compliance team that ensures site compliance, leads board of health inspections(in- person, remote and paper) and responses, liaises with Pfizer affiliates and regulatory bodies globally to support queries and certifications, drives inspection readiness and manages the internal auditing program,. This position also has responsibility for supplier audits, Site Quality Review Team (SQRT) facilitation, annual product record review (APRR), compendial change notifications and Pfizer Quality Standards (PQS) gap assessments. This position will serve as the Site Compliance Lead and will report to the Site Quality Operations Leader (SQOL).

  Key responsibilities are as following: Quality approval of Current Good Manufacturing Practices (cGMP) documentation; plans and executes highly complex projects; identifies continuous improvements and leads the implementation; and interfaces with and represents Quality Operations in cross-departmental/cross-site/cross-network meetings/summits. Represents Andover in network Site Compliance leader forums and Inspection Readiness governances.

  Eligible candidates should be able to demonstrate the following:

  • Broad depth of knowledge of GXPs and multiple functional area expertise to be a key leader and influencer of site compliance expectations.
  • Ability to generate and interpret metrics to support continuous improvement of quality and the business. Promotes and implements new processes and programs for quality improvement and business efficiencies. (e.g. leading yellow-belt or RFT activities).
  • Interprets BOH Regulations for applicability to the commercial and clinical environment. Capable of assessing and providing Site direction on new work.
  • Manages inspections for site audits/inspections. Ensures inspections are well-managed and mobilizes the Site to respond to inspection requests timely.Leads inspection communications with OpU Leadership. Post-inspection, ensures timely response process engages Site SMEs yielding thoughtful responses and appropriate actions.
  • Leads teams to make quality discussions, independently makes decisions based on sound judgement regarding complex quality and technical issues, and uses breadth of knowledge to contribute to broader strategies and decisions. Independently able to resolve complex issues. Represents Quality Operations in limited duration teams, cross-departmental/cross-site/cross-network meetings/summits.
  • Collaborates/independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
  • Can influence and negotiate with multiple business lines. Interacts constructively and shares experience of quality approaches with other groups developing key partnerships and actively sharing knowledge and expertise within multi
  • disciplinary teams.
  • Capable and experienced excellent decision maker who includes global Pfizer impact awareness on future quality and compliance thinking as apart of decisions
  • Uses other Pfizer Divisions information to obtain new ideas and/or benchmarking against when replicating best practices or new processes
  • Individual should have knowledge of US, EU, and ROW cGXPs; Microsoft Office™ applications specifically Word, Excel, PowerPoint, Access, and Project; Lean Six Sigma concepts; project management tools including stakeholder management; Quality Systems, and Quality Risk Management including risk assessments.

  ROLE RESPONSIBILITIES

  • Responsible for knowing, understanding, role modeling, and ensuring others follow the Pfizer’s values.
  • Manages the tasks/activities associated with maintaining cGXP compliant Quality Control or Quality Assurance systems/areas.
  • Responsible for review, approval and final authorization of cGXP documentation and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
  • Manage a working area and manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
  • Responsible for planning and managing the site internal audit program
  • S-QRT, inspection readiness, BOH inspection management, internal auditing, supplier audits
  • Serve on or lead cross functional teams to represent Quality Operations and facilitate communications and activities/projects between Quality Operations and site departments and/or Network. Interfaces with other parts of the organization such as Pfizer research and development groups and serves as technical SME for Quality Operations in these interactions.
  • Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
  • Plans and leads highly complex, high business impact projects to ensure their timely completion.
  • 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.
    Relocation support available

  BASIC QUALIFICATIONS

  • Bachelor's Degree in Science or related field required.
  • 12+ years of experience in a regulated environment.
  • 10+ years of experience in the biotech or pharmaceutical industry.
  • Previous experience leading a team required.
  • Prior successful interactions with Regulatory Agencies required.

  PREFERRED QUALIFICATIONS

  • Experience withing manufacturing, quality or engineering preferred.
  • Experience managing, directly influencing Board of Health inspections and successful interactions with inspectors preferred.
  • Preferred experience with Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWiseTM application), Systems, Applications, and Products (SAP).

  Other Job Details:

  • Eligible for Relocation Package

  • Eligible for Employee Referral Bonus

  • #LI-PFE

Work Location Assignment:On Premise

Last Date to Apply: August 19 2022

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

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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.