• Job Description

  Req#: 4889738

  Why Patients Need You

  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

  Pfizer has a scientific, ethical, regulatory and legal obligation to collect and evaluate safety information that may be associated with its products, as well as ensuring data privacy. As a leader in Quality Assurance, you will be working with a team whi c h is responsible for providing leadership in assuring that appropriate systems and processes are in place on site and in business units to meet or exceed the requirements of Pfizer and the regulatory authorities for the quality of the products manufactured on site or by approved vendors.

  Position Summary

  The 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 manufacture for sterile drug products. The SQOL partners with Site Operations other stakeholders to drive regulatory excellence, ensures a supply of quality products from the site which are compliant with regulatory requirements to meet customer needs and develops talent. The SQOL is accountable for the product quality, regulatory compliance, quality systems, and processes for the site (including 3rd parties under the responsibility of the site). The scope of this role also includes quality budget and resources planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects. The SQOL is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products with established specifications, compliance with regulations and other applicable standards.

  How You Will Achieve It

  • Assures overall quality/integrity of pharmaceuticals products manufactured and distributed in worldwide markets based on cGMP regulations and industry standards.

  • Provides leadership for the Quality unit responsible for compliance, documentation and laboratory operations.

  • Ensures establishment, implementation and adherence to quality pharmaceutical manufacturing standards.

  • Assures that all processes, systems, facilities, methodologies utilized in the manufacture/testing of pharmaceuticals are validated and fully integrated.

  • Establishes systems to assure the audit readiness of manufacturing /testing facilities by regulatory agencies and internal auditors.

  • Implements strong communication networks for information flow to and from the plant, senior management, staff groups and regulatory agencies. This includes a robust notification to management process.

  • Actively engaged in location leadership and site leadership initiatives.

  • Interacts with diverse stakeholders to achieve site goals.

  • Active member of Site Leadership Team to assure supply, financial commitments and consistently achieve common site goals.

  • Fosters a culture of continuous improvement and innovation at the site and play a lead role in protecting and strengthening the site quality culture.

  • Demonstrates a passion for Colleague Engagement and is an active change agent.

  • Accountable for staffing, training & development, motivation & coaching, giving feedback and effective listening & communication towards his/her colleagues.

  • The SQOL will respect the PGS vision, mission, values and leadership behaviors in order to realize the PGS objectives related to quality, cGMP, customer satisfaction, right first time and cost.

  • The leader focuses on the departmental objectives in support of the site and the PGS objectives.

  • Engaged in the external regulatory community.

  • Liase with other site QO leaders and Center QO to ensure aligned direction and response on specific topics at the Rochester site.

  • Keeps abreast of business and industrial conditions and broadens his/her knowledge of pharmaceutical production practices, regulatory, marketing requirements and company operations to focus on best practices for the Rochester site.

  • Ensures adoption and sharing of best practices across the Pfizer network.

  • Keeps abreast of evolutions in pharmaceutical production practices, regulatory requirements and company operations and cGMP's affecting all aspects of the pharmaceutical industry.

  • Has a reporting relationship to Cluster Quality Lead

  Qualifications

  • 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 and familiarity with Drug Product manufacturing

  • Experience leading people leaders.

  • Experience influencing Board of Health inspections and successful interactions with inspectors 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.
  

  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 with some exceptions to meet business needs. Some travel will be required to support network and sister site initiatives; ~10% required travel.

  
  Relocation support available

  
  Other Job Details:

  • Work Location Assignment: On Premise
  • Last day to apply: September 1, 2023

  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

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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