Sr MgrTL Compliance

Use Your Power for Purpose
The Quality Compliance Senior Manager/TL reports to the Quality Operations Director of Compliance & Systems and responsibilities include management oversight of the Quality Compliance Team and assessing regulatory compliance of the plant processes according to Pfizer Quality Systems and cGMP regulatory team will manage internal and external audits and inspections and utilize all sources of data and feedback to assess and enhance site Quality compliance.

What You Will Achieve
To manage and mentor a team of 50 Quality professionals and people managers to partner with other Pfizer Functional area personnel to assess and enhance the compliance status of the manage the hosting of external inspections/ audits including Regulatory Board of Health Authorities PC1 customers and Pfizer Regulatory Quality Audits (RQA).Oversight of audit and inspection responses facilitating site and above site reviews and championing implementation of lessons and conduct routine internal audits to assess on-going cGMP compliance and provide actionable opportunities for continuous for providing leadership strategic direction and oversight for Site Inspection for providing leadership strategic direction and oversight for the management of quality risk management program customer complaints stability and -ordinate the generation and compilation of product Annual Product Record Reviews (APRRs).Responsible for management Pfizer Quality Standards/Compliance Assessment (PQS/CAS). Co-ordinate the Site Management Review of quality systems and compliance by convening regular Site Quality Review Team (SQRT). Develop and implement chemistry manufacturing and control (CMC) regulatory strategies for small and large molecule pharmaceuticals and devices to meet global regulatory requirements throughout the life cycle.

People Leader
Ensure individual and team training is up to date relative to the duties being performed. Responsible for development of direct reports and others. Sets expectations for goal setting ongoing assessments and coaching/performance evaluations to motivate direct reports and deliver results for the department and business lines. Identify growth and development opportunities for direct reports. Respects the PGS vision mission values and leadership behaviors in order to realize the PGS objectives related to quality GMP customer satisfaction right first time and cost.

In this role you will:

• Ensure effective processes and resources for meeting complaint handling timelines and notification requirements

• Confirm compliance with Global SOPs complete gap analysis reports and provide necessary training

• Lead preparation and coordination for GMP GCP GDP and MAH inspections by Regulatory Authorities or internal auditors

• Oversee quality of local contractors including Logistic Service Providers re-labelers re-packers and other applicable contractors

• Identify and implement quality continuous improvement efforts to enhance compliance and efficiency

• Set objectives for direct reports aligned with global and local business goals and ensure frequent review of these goals

• Ensure all colleagues have Individual Development Plans that align with their development needs and the organizations vision

• Provide technical and functional leadership manage direct reports and ensure alignment with company compliance and quality standards

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 6 years of experience or MBA/MS with at least 5 years of experience or PhD/JD with at least 1 year of experience or MD/DVM with any years of experience

• Demonstrated expertise in people management and a proven track record of leading high-performing teams

• Exceptional leadership skills along with strong verbal written and interpersonal communication abilities

• Proficiency in word-processing spreadsheet and presentation software

• Familiarity with role-specific tools like LabWare LIMS

• Strong understanding of quality assurance and compliance processes

• Ability to manage multiple projects and set objectives for direct reports

• 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.

Bonus Points If You Have (Preferred Requirements)

• A Masters degree with relevant pharmaceutical experience

• An excellent understanding of local regulations surrounding good manufacturing practices for finished pharmaceuticals

• A good grasp of risk management methodologies with a proven ability to apply them to Bio-pharmaceutical operations

• Strong problem-solving skills and the ability to develop solutions to highly complex problems

• Ability to champion innovation and take appropriate risks

• Excellent interpersonal skills and the ability to influence senior management decisions

• Experience in managing direct reports and ensuring their alignment with company standards

Physical/Mental Requirements

N/A

Non-Standard Work Schedule Travel or Environment Requirements

Minimal travel may be required.

Work Location Assignment:On Premise

Other Job Details:

• Last Date to Apply: September 25 2025

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