Senior Manager, Stability Administration & Rapid Action at Pfizer in Rocky Mount, North Carolina

Job Description:

ROLE SUMMARY

 

The Senior Manager for the Stability Administration and Rapid Action teams is responsible for providing strategic leadership for managing functions of stability operation, investigation of significant quality events, and quality improvement initiatives at the Rocky Mount Facility.

 

Key responsibilities include providing strategic direction to management of stability operation to meet defined quality standards and objectives; comply with global regulatory requirements and stability commitments; manage submission-ready stability protocols and reports; support stability needs for new product launches and/or filing updates. Facilitate collaboration with the broader Quality organization to optimize investigation processes, ensuring timely completion of investigation to allow timely closure of significant investigations and to identify effective CAPAs to resume compliant cGMP activities. The Senior Manager will also provide technical support to the Rapid Action Investigations team, participating in cross-functional teams to resolve technical challenges and to support quality functions to maintain compliance with the site cGMP and regulatory requirement, such as FAR, AQRT, eSQRT, etc.

 

The Senior Manager will ensure cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the department and the function, and plan, organize, and evaluate activities across these teams to ensure alignment with operational goals and long-term site initiatives.

 

Experience in management of stability operations and investigation of significant event is required, along with a working knowledge of relevant regulations. The Senior Manager is expected to frequently visit the manufacturing floor to ensure compliant cGMP activities at the site, gain an understanding of manufacturing processes, and drive improvements across the labs in support of site metrics and initiatives.

 

Additional responsibilities include implementing and managing quality improvement initiatives for the site, driving continuous process improvements, optimizing resources, and supporting the implementation of IMEX across the teams.

 

A deep understanding of ICH and regulatory guidance and investigational principles is required. The incumbent must be able to work cross-functionally to support commercial manufacturing activities and product stability monitoring activities.

 

The Senior Manager will advise Quality Leadership on stability administration, providing data analysis and trend insights to ensure compliant cGMP operations in stability operations and significant event investigations. Experience in presenting technical materials to regulatory auditors, such as the FDA, TGA, and MHRA, is also required.

 

ROLE RESPONSIBILITIES

 

• Serve as the technical and functional expert, providing leadership and direction for the site's stability administration.
• Lead and actively participate in lean initiatives/projects to drive continuous improvement across the laboratories.
• Conduct routine assessments of stability administration, significant event investigations, quality improvement initiatives and collaborate with management to identify opportunities for enhancement, developing strategies and action plans for improvement.
• Ensure the availability of comprehensive training and coaching resources for Stability Administration and Rapid Action Investigation teams to support site objectives.
• Influence best practices across the network by actively contributing to global discussion groups and collaborating with user council representatives to drive system improvements.
• Manage resources effectively to achieve organizational goals, including leading, developing, and engaging a diverse team of colleagues through performance reviews, development discussions, team building, and fostering a results-driven culture.
• Build and maintain relationships across multiple organizations to ensure consistent site practices that align with local, corporate, and regulatory requirements.
• Uphold site safety objectives by maintaining a safe working environment, including adherence to 5S principles and ergonomic standards.
• Promote a culture of lean operations by systematically reviewing and refining existing work practices to eliminate non-value-added activities.
• Establish and enforce standards, processes, and procedures to ensure compliance with regulatory requirements and Pfizer Quality Standards for stability operation and deviation investigation activities.
• Provide strategic direction to the Stability Administration and Rapid Action Investigation teams to align with long-term site goals, PQSs, BOH requirements, and evolving industry standards.
• Collaborate with key stakeholders at both site and corporate levels to analyze metrics and ensure ongoing compliance with stability operations and the site's cGMP activities.
• Provide overall strategic direction to the teams, ensuring that initiatives align with the site's goals. Collaborate with other quality departments to support the manufacturing and release processes. Optimize quality performance to align with and support the site's long-term initiatives.
• Lead a multi-tiered, highly technical team, serving as a subject matter expert on stability operations and significant deviation investigations.
• Provides strategic input to site leadership on initiatives impacting the quality organization to ensure the site's cGMP activities are compliant.

 

Qualification:

 

Applicant must have a HS Diploma / GED with 15 years of relevant experience in pharmaceutical quality operation; OR an Associate's Degree with 10 years of relevant experience in pharmaceutical quality operation; OR A Bachelor's Degree in a technical or scientific field, such as Engineering/Microbiology/Biology/Chemistry or other related science fields with seven years of relevant quality operation experience; OR Master's Degree with more than six years of relevant quality operation experience.

 

• Must have 3+ year as a people management experience
• Excellent communication (oral/written), facilitation and presentation skills, deliver with passion and pride.
• Good knowledge of GMP and Regulatory compliance as related to aseptic manufacturing
• Experience in Technical Training Skills..

 

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.

 

PHYSICAL/MENTAL REQUIREMENTS

 

Use computer terminal. Ability to wear appropriate PPE/gowning. Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis. Capable of utilizing soft skills to coach and correct personnel on performance concerns.

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

Must be able to work on weekend, off shifts and holiday as business demands

 

Work Location Assignment: On Premise

 

The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.

 

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