Manager Investigations (1st shift) 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

 

In your role, you will help us in investigation of any quality issues in manufacturing and quality laboratories. You will work with a team to investigate deviations, out-of-specification results and atypical result investigations. Your problem - solving skills will help to identify assignable/root cause and suggest appropriate corrective action plan. Your attention to detail will help us ensure that the reports are aligned to regulatory requirements and company policies.

 

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 a nd lead projects and m anage own time to meet objectives .
• Forecast and plan resource requirements (people, financial and technology) for projects.
• Act as Subject Matter Expert for the Investigations group, mentoring and providing guidance to other colleagues.
• Provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all Manufacturing Investigation Reports (MIR) and Laboratory Investigation Reports (LIR), Corrective Action and Preventative Action (CAPA), evaluation of CAPA effectiveness through Effectiveness Check (EC) and Operational Excellence (OPEX) projects within assigned unit .
• Assist the manager of investigations in transforming the investigation process on site including development and implementation of Continuous Improvement (CI) initiatives and techniques.
• Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards.
• Manage investigations and apply relevant and necessary actions/systems to ensure appropriate levels of compliance.
• Ensure investigations are evaluated and closed out in a timely manner to meet business needs.
• Review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected GXP standards.
• Prepare and approve regular reports on department performance and quality issues.
• Evaluate data, trends and report results to management.

 

Qualifications

 

Must-Have

 

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an associates degree with 8 years of experience OR a bachelors with at least 5 years of experience OR Masters Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.
• Effective team building skills.
• Strong oral and written communication skills.
• Proficiency in deviation management system s .
• Experience with six sigma methodologies .
• Experience writing Manufacturing Investigation Reports (MIR) and/or Laboratory Investigation Reports (LIR).

 

Nice-to-Have

 

• M1 and PHP education and experience and Continuous Improvement ( Green/Black belt ) certification.
• Strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring .

 

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

 

• Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.

• Limited travel for the position; no more than 15% traveling.

 

Relocation support available

 

Work Location Assignment: Hybrid

 

Last Day to Apply: November 21st, 2024

 

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.

 

Quality Assurance and Control

 

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