• Job Description

  Req#: 4909256

  Senior Compliance Specialist II

  ROLE SUMMARY

  The Senior Compliance Specialist II, Clinical Manufacturing, is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio. The position is located in Andover, MA.

  The Senior Compliance Specialist II is responsible for ensuring a strong compliance culture and maintaining processes to drive high standards of data integrity, quality and compliance. This role provides oversight of the compliance program and its associated elements with focus on ensuring alignment with internal and external quality and regulatory standards. Additionally, the Senior Compliance Specialist II will have primary responsibility for supporting audits and the implementation of quality initiatives.

  The Senior Compliance Specialist II will interact with internal Pfizer teams (operations, technology transfer, quality and engineering groups), as well as external boards of health agencies.

  ROLE RESPONSIBILITIES

  • Lead cross-functional teams, working effectively in a highly matrixed team environment to advance Pfizer’s clinical portfolio.
  • Manages compliance related metrics, communication and/or presentation of compliance status and progress toward meeting commitments.
  • Provide input supporting revisions to policies and procedures, and complete gap assessments against established standards.
  • Represent Andover Clinical Manufacturing at Compliance Forums and support Quality leadership efforts and initiatives.
  • Partner with Validation team to develop and implement instrument and equipment validation lifecycle processes that incorporate regulatory guidance and Pfizer compliance expectations.
  • Lead audit and compliance strategy implementation efforts, including inspection readiness, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
  • Manages compliance related tasks such as facility access reviews.

  REQUIRED QUALIFICATIONS

  • Masters degree with 3 years of experience, Bachelors degree with 5 years of experience, or Associates degree with 7 years of experience, in a scientific or engineering discipline in a cGMP manufacturing environment.
  • Strong experience with biotechnology processes.
  • Strong attention to detail, along with excellent verbal and written communication skills.
  • Strong decision-making skills, routinely demonstrated in highly complex environments.
  • Able to work with cross-functional areas such as quality, manufacturing, and engineering, in a matrix environment.
  • Ability to flex and quickly adapt to changing environment and competing priorities.

  PREFERRED QUALIFICATIONS

  • Experience in a Quality role preferred
  • Experience participating in audits

  PHYSICAL/MENTAL REQUIREMENTS

  • Ability to effectively gown into a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves

  • Ability to stand and walk for extended periods of time.

  NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  Off shift coverage, or holiday coverage, though rare, may be required.

  
  Work Location Assignment: On Premise

  
  

  The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

  Relocation assistance may be available based on business needs and/or eligibility.

  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. This position requires permanent work authorization in the United States.

  Manufacturing

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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