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Principal Scientist: ARD Instrument Systems and Compliance Lead

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Closing date
May 17, 2022

View more

Discipline
Physical Sciences, Chemistry, Other, Legal/Regulatory Affairs
Position Type
Full Time
Job Type
Staff Scientist
Organization Type
Pharma
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Why Patients Need You

Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

What You Will Achieve

The Principal Scientist will support the delivery of the ARD (Analytical R&D) compliance, instrumentation, and data integrity strategy. This matrixed role will interface with the multiple ARD functions as well as strategic partners such as Quality Assurance, Digital Strategy, and Pharmaceutical Sciences to ensure compliance with applicable procedures and policies and the implementation of a robust data integrity program. The candidate must be able to interact effectively with highly interdisciplinary teams, in a cross functional environment. This candidate is accountable for enhancing the overall Quality culture and maintaining an audit and inspection ready state (in partnership with ARD management).

Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.

How You Will Achieve It

The purpose of this position is to ensure a strong compliance culture and maintain processes to drive high standards of data integrity, quality, and compliance. The candidate will proactively drive departmental initiatives to enhance the overall Quality culture and continue the development and implementation of the data integrity strategies across ARD. The candidate will liaise with appropriate departments, functions and SMEs regarding compliance and data integrity related programs, questions, and communications.

This role will also focus on compliance with applicable SOPs, policies, and compliance. This role could also include investigations authoring point of contact/author, CAPA management, Investigations support, vendor support, ARD Quality Council representation, instrument validation lifecycle support, and other compliance responsibilities to enhance the overall Quality Culture within ARD and drive compliance and quality standards.

Accountability for continuous improvement initiatives for the ARD organization in areas such as data review, specification review and approval, Instrument systems, ARD project team interfaces with GMP functions and data integrity initiatives are important for this role. The role will also assist teams in continuous improvement efforts at the interface of ARD laboratory quality systems and bridging technical needs with quality requirements.

Additional responsibilities are/may be:
  • Managing compliance related metrics
  • Optimization and implementation of Pfizer Quality System (PQS) elements that impact or potentially impact ARD, including review and oversight.
  • Completion of assessments associated with new or revised PQS
  • Contribute/lead to the ARD Compliance Forum and support Quality Council and similar Quality leadership efforts and initiatives.
  • Partner with other business lines to develop and implement instrument and equipment validation lifecycle processes that incorporate regulatory guidance and Pfizer compliance expectations
  • Support audit and compliance strategy implementation efforts, including inspection readiness training, coordination of audits and inspections, CAPA resolution, and timely response to audit activities.
  • Support data integrity efforts as needed, including detection of potential gaps and partnership with laboratory personnel for remediation efforts.
  • The colleague must work within corporate guidelines and must appropriately record, archive and report all data in a compliant manner. The colleague must be able to interact effectively with peers and leaders as part of a multi-disciplinary team.


Qualifications

Must-Have

  • Bachelor's Degree in chemistry or engineering, or related field with 9+ years of industry experience, Master's Degree with 7 + years of industry experience or PhD with 4+ years of industry experience
  • MINIMUM: Five to 10 years of industrial experience in a quality or compliance related field.
  • Experience working in a regulated environment (e.g. GLP, cGMP).
  • Proven record of strong technical skills and scientific/engineering expertise in equipment validation.
  • Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
  • Demonstrated technical writing skills.
  • Outstanding leader behaviors and the ability to collaborate with and mentor others is a must.


Nice-to-Have
  • Experience with data integrity approaches and instrument qualification strategy is preferred.
  • Direct experience working with auditors or inspectors e.g. FDA or European regulatory authorities.
  • Experience in GMP environment and implementation of continuous improvement practices. Working knowledge of Quality Management Systems, quality tracking systems and Risk management.
  • Comfortable and effective in a team-based, fast-paced environment where multi-tasking is required
  • A record of external presentations (oral, poster and/or publications) in relevant field
  • Verbal and written communication skills
  • Awareness of pharmaceutical regulatory requirements


Other Job Details
  • Last Day to Apply: June 6, 2022
  • Eligible for Employee Referral
  • Eligible for Relocation Package


#LI-PFE

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.

Research and Development

#LI-PFE
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