Manager Quality Assurance
Location
Sanford, NC | United States
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 All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishing and implementation of the validation strategy for a given sector of validation (i.e. equipment, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.
As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It - Provide guidance, lead , or co-lead projects, manage own time to meet objectives .
- Forecast and plan resource requirements (people, financial and technology) for projects across the division.
- Plan and coordinate the validation/qualification work assigned, including Validation Plans, Validation Strategy, Requirements Specifications, Qualification protocols and Impact / Risk Assessments.
- Review and approve change controls including assessment for validation impact and identification of appropriate testing to ensure maintenance of the validated state.
- Work with Operations, Quality, Technical groups and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.
- Ensure the validated state of equipment, instruments and systems supporting manufacturing is compliant with corporate policies and regulatory requirements.
- Provid e technical support and participat e in the implementation of change controls and commitment action items.
- Prepare material for and deliver validation training on validation topics , includ ing, training on guidance/best practices, or site-specific requests for validation workshop training.
- Provide support to project teams on compliance and technical issues related to validation to ensure compliance with company policies and government regulations.
- Review and approve investigations, commitments and procedures and maintenance work orders as they relate to validation.
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 degree with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
- Experience in pharmaceutical industry
- Knowledge of GMP regulations/guidance(21 CFR Parts 11, 210 & 211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
- Experience in Quality, document management, protocol review and validation document check
- Background in problem solving, negotiations, data integrity principles and project management/support in a matrixed reporting environment.
- Good understanding of risk management methodologies, with a proven ability to apply to Bio-pharmaceutical operations.
- Excellent communication skills and able todeliver effective presentations to a variety of audiences.
- A bility to build relationships with internal and external stakeholders to influence outcomes .
- High proficiency in Word, Excel and have demonstrated aptitude for computerized systems.
Physical / Mental rquirements - Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and ability to perform data analysis.
Non-Standard work schedule, travel or environment requirements - Schedule is primarily day shift but may require off-shift work on occasions.
- The position may require working on the floor in manufacturing at times which will require a heightened safety awareness and aseptic gowning will be required.
Other job details - Last day to apply: March 14th, 2024
- Employee Referral Bonus eligible
Work Location Assignment:On Premise
Work Location Assignment:Flexible
The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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.
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