QC Sr Manager, Method Transfers and Validation

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

In this position, you will be joining our Quality Operations department which performs critical Quality Control activities. Through collaboration with supporting Quality Control (QC) Laboratory and Manufacturing teams, you will be part of a team which is responsible for providing oversight on analytical technology transfer activities (both into and out of the site). Your work will help the department to build the capabilities and systems to run a more robust Laboratory operation including the organization of long range manpower forecast and finite planning around department specific and routine QC Laboratory operations.

As a Senior Manager, you will be setting the objectives for multiple projects in your division. Your managerial and technical skills will help in guiding the people in your division. Your understanding of the external marketplace and customer requirements will facilitate in instituting knowledge sharing practices in your team and outside. You shall be relied on to strategically manage operational activities that support the goals of the division and sets direction for its success.

Through your expertise and extensive knowledge, you will be able to foster a culture that promotes innovation and thrives on doing better for patients and healthcare.

How You Will Achieve It

• Set objectives for and manage multiple projects/ ongoing work activities within Operating Unit.
  
• Provide support as needed to Quality Operations, Production and Engineering to assess product and process aseptic issues.
  
• Participate in internal and external quality assurance assessments and in the assessments of contract operations that supply drug products to Pfizer locations if required.
  
• Ensure standardized Quality Control (QC) practices and systems across all QC functional areas and drive the implementation of Operational Excellence best practices and tools in support of an efficient QC operation.
  
• Develop analytical methods as required to support current and new product introductions, including the creation and validation of analytical methods for cleaning validation activities.
  
• Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
  
• Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement.
  
• Support continuous process performance evaluation and continuous process improvement for highest effective and efficient process operations.
  
• Provide a strategic vision for the MTV team and manage, develop and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
  
• Ensure the delivery of an excellent customer service to all internal and external customers of the quality control department.
  

Qualifications

Must-Have

• Bachelor ' s Degree and 7+ years of analytical and/or method transfer experience .
  
• People Management experience.
  
• Excellent verbal, written and interpersonal communication and presentation skills.
  
• Strong knowledge of regulatory requirements and ICH guidelines, as they relate to method transfer and validation activities.
  
• Previous experience supporting method transfer and/or method validation work in a GMP environment.
  
• Comprehensive knowledge of analytical techniques in Chemistry, Bioanalytical, or Microbiology.
  
• Relevant pharmaceutical experience.
  

Nice-to-Have

• Master ' s degree in pharmacology, chemistry, bioanalytical, microbiology or related area .
  
• Strong and thorough knowledge and understanding of GMP, GLP .
  
• Comprehensive knowledge of analytical techniques [Chemistry, Bioanalytical, and Microbiology] and laboratory equipment.
  
• Knowledge of six sigma, lean labs and standard work practices.
  
• Experience in Empower software.
  
• Experience leading people leaders and directing a large, complex organization .
  

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

Sitting, standing, walking, bending, ability to perform complex data analysis

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Off shift hour support might be needed depending on the projects being supported.

Work Location Assignment:On Premise

Last Date to Apply to Job: March 26, 2024

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.

Quality Assurance and Control