VP Quality, Sterile Injectables US

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
May 16, 2022
Ref
4852725
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Reporting to the VP Quality Operations (QO), Global Sterile Injectables (GSI), the VP QO Sterile Injectables (SI) US has quality oversight responsibility for the manufacturing sites in Rocky Mount, North Carolina and McPherson, Kansas, and oversees the supplier quality management team of subject matter experts. The VP QO SI US provides strategic and tactical leadership to the site quality organizations as well as ensuring that Pfizer Quality Standards and cGMP requirements for manufacture are implemented and consistently followed. He/she is a member of the GSI QO Leadership Team, the SI US Leadership Team and will be responsible for actively developing and contributing to network initiatives.

Position Responsibilities
  • Provides strategic and tactical leadership to the SI US site QO units on all matters related to quality and GMP compliance

  • Develops regulatory strategies in response to concerns/questions raised by regulatory agencies

  • Chairs AQRT meetings for issues impacting distributed product and supports quality investigations to ensure that appropriate decisions are made

  • Leads a team of 5-7 direct reports, and indirectly responsible for ~950 QO colleagues.

  • Reviews and endorses site QO budgets, staffing plans, QO organization and hiring/development of colleagues for key site QO positions (including Site Quality Operations Leaders)

  • Conducts/supports performance assessments of site QO leaders

  • Ensures that sites monitor, trend and report Quality metrics in a highly disciplined way to drive continuous improvement and ensure a compliant state is maintained

  • Fosters a culture where innovation, science and risk-based quality and colleague engagement thrive, sharing best practices across the network

  • Serves on the GSI QO Leadership Team, participating in multiple initiatives that will enable global network goals

  • Collaborates closely with the VP, SI US and serves as a member of his/her leadership team

  • Collaborates with the Quality Excellence Team and other resources for successful remediation to ensure compliance

  • 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.

QUALIFICATION

Education:

  • Bachelor’s Degree in microbiology, chemistry, engineering, or related scientific discipline.

Experience:

  • Minimum 15 years of relevant experience in pharmaceutical quality roles, including extensive commercial manufacturing expertise with a thorough understanding of quality systems and compliance requirements.

  • Expertise and substantial experience in manufacturing and/or quality oversight of parenteral products is required.

  • The candidate must have had site operational or center experience in a GMP-regulated environment, involving quality decision making, with a proven track record of effectively supporting a moderate to large size quality unit. Multi-site leadership experience is desirable.

  • Demonstrated experience in quality decision-making in a highly complex environment is essential.

  • Additionally, the successful candidate must be flexible with regard to changing and conflicting priorities, able to easily shift gears in terms of behavior and attitude in response to ambiguity and the needs of the situation.

  • Candidates will need the ability to address obstacles with energy and determination and exhibit commitment to change and passion for Pfizer's best interests.

  • Candidates should have the leadership skills necessary to engage, influence and motivate colleagues at all levels in the organization at all times, especially during periods of intense change.

  • The ability to communicate effectively at all levels of the organization is essential.

  • Willingness to be inclusive and embrace team principles is necessary.

  • The candidate must be self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.

  • 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

  • Strong knowledge of US, European and global cGMPs, compliance issues, inspectional trends, and industry quality assurance practices and systems.

  • Proven analytical skills capable of evaluating complex data to identify trends and signals.

  • Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others, participate in teams at all levels of management and achieve results through others.

  • Must be fluent in English.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Based on the nature of this role travel is required (up to 20%).

ADDITIONAL POSITION DETAILS

  • Last Date to Apply - May 19, 2022

  • Relocation support available

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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