Head of Technical Operations-Instrument and Computer System Validation at Pfizer in Sanford, North Carolina

Job Description:

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

 

You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight. Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.

 

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.

 

It is your managerial skills and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe.

 

How You Will Achieve It

 

• By providing leadership, supervision and performance management to the Computer System Validation team. Establishes team goals, objectives and performance expectations for direct reports and the department. Provide priorities, ongoing feedback and recognition.
• Requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, area management and site leadership up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.
• Participating in right-first-time and continuous improvement relative to supported validation programs (processes or procedures).
• Provides leadership and support for the qualification, verification and validation of computer systems and controls in compliance with internal guidance & external regulations.
• Remains up-to-date on current Regulatory trends as well as Pfizer Quality Standards.
• Maintains Requalification and Periodic review program for all GMP analytical instrumentation.
• Demonstrates a flexibility and agility to fit any future business needs.

 

Qualifications

 

Must-Have:

 

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associate's degree with 8 years of experience OR a bachelor's with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0-2 years of experience.
• Demonstrated experience with computer system validation - life cycle management.
• Experience with analytical instrument validation, Data Integrity, Risk Based Approach and GAMP requirements.
• Successful track record of continuous improvement and development / implementation of best practices in Quality Operations or manufacturing
• Knowledge of national and international regulations relevant to the production and control of pharmaceutical products
• Knowledge of Quality Management System applications, MS Word and MS Excel
• Previous people management experience.

 

Nice-to-Have:

 

• Master's degree
• Understanding of Computer Software Assurance approach
• Experience in aseptic manufacturing
• Highly motivated, organized and able to work effectively in a demanding environment with flexibility to changing priorities

 

Physical/Mental Requirements:

 

• Office and plant environment, able to enter and navigate cleanroom type environments in manufacturing facilities

 

Non-Standard Work Schedule, Travel, or Environment Requirements:

 

• Schedule is primarily Monday - Friday day shift, but at times it will be necessary to work additional times to support emergency manufacturing needs (either onsite or remote)

 

Other Job Details:

 

• Last day to Apply: December 13th, 2024
• Eligible for Relocation Assistance: Yes
• Work Location Assignment: On site

 

#LI-PFE

 

The annual base salary for this position ranges from $109 400,00 to $182 300,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15,0% 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

 

#LI-PFE Apply Now