Job Description
The "Senior Issue Lead, Inspections" will be accountable to drive GCP quality in withstanding regulatory scrutiny, operational data and documentation. Major areas of focus will include:
- Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities
- CAPA management
Inspection Coordination
This individual may be assigned additional focus areas in inspection coordination, including inspection responsibilities around:
- Directing asset/study team colleagues within CS&O/Clinical to ensure successful inspection and audit outcomes
- Leading key activities in the inspection control room as required
- Communicating audit and inspection progress and needs to CS&O/Clinical stakeholders
- Serving as the point of contact for Regulatory Quality Assurance related to inspection CAPA management
Quality Compliance Assessment
Plan, lead and report out on Quality and Compliance Assessments related to CS&O processes.
Training and Technology
This individual will also be required to mentor and train Issue Leads to ensure the individuals coordinating inspection readiness, and those providing inspection support are qualified to assess and support inspections.
BS – 10+ years or equivalent MS/MBA – 9+ years or equivalent
Previous Experience:
- BS – 10+ years or equivalent MS/MBA – 9+ years or equivalent
- Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory quality
- Regulatory inspection experience
- Process and system management experience
- Detailed knowledge of clinical trial processes and relationships required
- Knowledge of GCP requirements and applicable SOPs and regulations
- Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
- Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
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.
#LI-PFE
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.
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.
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