Rocky Mount Site Quality Head

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

The Rocky Mount Site Quality Operations Leader (SQOL) is responsible for the operational and strategic management of a diverse range of quality control, quality assurance and quality system operations to support Commercial and Clinical manufacture and packaging of sterile and non-sterile drug products, including medical devices. The SQOL partners with all site functions, other Pfizer site SQOLs, and other stakeholders to drive regulatory excellence, to ensure supply of quality products which are compliant with regulatory requirements, and to develop talent. They lead and drive a Quality mindset across the site leadership team and across all Rocky Mount colleagues.

The SQOL is accountable for the product quality, regulatory compliance, and quality systems and processes for the site (including 3rd parties under the responsibility of the site). The scope of this role includes quality budget and resource planning, quality performance metrics tracking and improvement, quality strategic planning, quality goals and objectives, and quality projects. The SQOL is accountable for providing leadership to the site in establishing and maintaining compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products. Ensures that products comply with established specifications and are in compliance with regulations and other applicable standards. The incumbent is responsible for working closely with Pfizer Global Supply (PGS), Worldwide Research and Development (WRD) and Global Regulatory Affairs (GRA) teams to develop strategies on new product introduction.

This position reports to the Sterile and Biologics Operations (SBO) Cluster 3 Quality Operations Leader and is a member of both the Rocky Mount Site Leadership Team (SLT) and the Cluster 3 Quality Leadership Team.

How You Will Achieve It

Regulatory Excellence : Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful Board of Health inspections. Creates effective relationships with BOH to create trust and credibility. Prepares the site for changes to regulations. Ensures compliant site Quality Systems and marketing authorizations.

Product Disposition : Ensures independent and timely product disposition using validated processes, analytical methods, and documented decision-making.

Product Testing : Ensures independent and timely product testing and test result reporting using validated test methods and compliant test equipment.

Issue Resolution : Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.

Safety: Ensures that all QO operations are performed in a safe environment in accordance with all applicable EHS policies and procedures.

Operational Excellence : Drives innovation and continuous improvement in all QO activities. Supports operational excellence throughout the site.

High Performance Culture : Creates a high achieving Quality Operations team with goals and values aligned with the site’s goals and values. Fosters a collaborative team environment and high-performance culture within the Quality Operations organization.

Talent Management : Oversees the Talent Management programs to develop Quality operations colleagues, to create future Pfizer leaders and to ensure robust succession plans for the Site Quality Operations Organization. Directs, oversees, and participates in the recruitment, selection, promotion, termination and performance management of Quality colleagues and site personnel in leadership and critical roles.

Pfizer Quality System : Responsible for the implementation of all Pfizer Quality Standards. Ensures that the quality system requirements are effectively established and maintained in accordance with regulatory compliance. Ensures the quality policy is disseminated across all levels of the organization. Reports on the performance of the quality system to Management with Executive Responsibility, including the adequacy and effectiveness of the quality management system and any need for improvement. Ensures that the quality management system processes are documented.

ICH and Industry Standards : Drives understanding of ICH Q8, Q9, Q10 and other appropriate industry standards across the site organization. Anticipates the impact of emerging regulations on site operations and prepares the site for implementation and change, as appropriate.

Quality Technical Support : Fosters science through the establishment and work of the Quality Technical Support function

Technology and Science : Holds self and others accountable for making decisions, solving problems, or driving improvements through a sound understanding of the technology and science of the products.

Regulatory Compliance: Ensures that there is awareness of the applicable Regulatory Compliance and QMS requirements throughout the organization.

Relationships : Is an active member of the Site Leadership Team. Achieves compliance and business results through partnerships between Quality, Operations, and other site/cross site functions e.g PharmSci, Regulatory, Co-Development teams, etc.

Qualifications

Must-Have

• 15 or greater years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
• Greater than 10 years of Quality Operations experience
• Familiarity with Drug Product manufacturing and packaging
• Experience leading people leaders and directing a large, complex organization. Previous Site Quality leadership experience preferred.
• Experience influencing Board of Health inspections and successful interactions with inspectors.
• Ideal candidates will have prior experience and demonstrated success in most, if not all, of the following:
• Making sound and effective decisions under pressure
• Managing a Quality/Operations function with product test and disposition responsibilities
• Experience in at least two quality and/or science areas
• Working in functions outside Quality/Operations, e.g., Technology, Validation, Operations, Regulatory
• Advancing a quality culture in a manufacturing environment
• Working with other manufacturing and R&D sites to understand a broader perspective.
• Exposure to Regulatory inspections including interactions with Board of Health representatives and responding to Board of Health observations.
• Working with multicultural, cross-functional work teams
• Evaluating and continuously improving site Quality Systems
• Project management
• Finance planning and budgeting
• Developing and implementing a quality business strategy
• 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

Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Primarily standard work hours at the Rocky Mount site with some exceptions to meet business needs. Some travel to support network and sister site initiatives; ~5% required travel.

Other information:
Last date to apply: 1/29/24
Relocation support available
Work Location Assignment:On Premise

The annual base salary for this position ranges from $191,300.00 to $309,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 22.5% 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 tendersglobal.net (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.

Quality Assurance and Control

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