Why Patients Need You
At Pfizer, our mission is to inspire a best-in-class culture of continuous improvement and project management that empowers colleagues and enables simple, effective processes. Whether you are managing projects or liaising with others, your contribution in this team will help in making our work easier and faster so that we can deliver breakthroughs that change patients' lives.What You Will Achieve
The primary function of the Quality Engineering Program Manager is to strengthen Quality Systems and support the continuous improvement process by providing technical support to various Rocky Mount Quality units.:
How You Will Achieve It
- Drives execution of significant risks/size lab compliance and equipment/instrumentation initiatives.
- Ensures efficient achievement of project deliverables and timeliness of project completion.
- Tracks and reports project stats, delays, roadblocks to the director and Process owner.
- Facilitates problem solving of issues and roadblocks through engaging the RMQC in identified issues.
- Tracks all other identified commitments to ensure independent checking of completion. Work with Quality Systems and Compliance to confirm effectiveness of completed commitments.
- The PM will work collaboratively with the Process owner and the Team Leader as well as functional peers across Quality, Operations, Regulatory Affairs, and any other impacted functions.
- The PM will work collaboratively with the Process owner as well as functional peers across Quality, Operations, Regulatory Affairs, and any other impacted functions.
- Prepares schedules for the execution of projects/programs and documents project team activities ensuring delivery to team commitments.
- Ensures a robust process is developed by ensuring decision making is driven by quality needs and balances the delivery expectations of the business appropriately.
- Engages, influences, and coordinates all functions involved in the project.
- Facilitates resolution and appropriate escalation of conflicts within the team and with other stakeholders to ensure project success
- Submit annual budget and capital requests for support assigned projects or compliance programs.
- Participate and provides input, including appropriate documentation, in performance evaluation of project team members.
- Periodically performs lab instrument validation and reviews.
- Where required, may initiate and own investigations associated with unexpected events in programs/projects.
- Act as subject matter expert during regulatory and customer audits of Rocky Mount.
- Defining and recommending corrective and or preventive actions for investigation or audit observations.
- Manages metrics associated with Quality and Cultural Transformation to ensure understanding of changes and progress.
- 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, science or engineering related discipline preferred, 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.
- Experience in an FDA regulated industry.
- Knowledge of quality operations processes.
- Demonstrate ability to work/contribute in a team-based environment as a lead and a participant with exceptional interpersonal skills and adept problem-solving skills.
- Proficient knowledge and understanding of pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPs, ICH, USP, FDA and other applicable industry guidelines.
- Strong organizational, presentation, meeting facilitation and technical writing skills.
- Strong critical thinking and problem solving skills
- Understanding of basic management skills including, but not limited to task delegation, scheduling and prioritization.
- Widespread knowledge of manufacturing-facility processes and materials needed.
- Display familiarity with the non-conformity and resolution process.
- Mastery of core computer software/systems (Word, Excel, Project Trackwise, etc.).
- Program Management Professional Certification
- Preferably 1-3 years of experience within Quality Assurance, Compliance Auditing, Investigation, or Validation cGMP Compliance.
- Professional certifications desirable but not required (i.e. CQA-Certified Quality Auditor, CQE-Certified Quality Engineer, etc.).
- 1+ years of experience in the validation of laboratory instruments including those with computerized systems attached in a biotechnology or pharmaceutical cGMP manufacturing environment
- Hands on experience operating/validating various laboratory instrument systems (e.g. AA, FT-IR, IC, ICP-MS, TOC, UV_Vis).
- Lean Sigma Greenbelt Certification
- Mathematical and scientific reasoning ability.
- Occasionally lift a computer system and/or instrument up to 50 pounds.
- Use a computer terminal for up to 8 hours per shift, work around moving equipment, work with biological and chemical materials.
- Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Primary work schedule is Day shift, Monday – Friday but evenings, weekends and holidays will be required, as needed to support laboratory processes at the Rocky Mount site.
- Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.
- Work safely in laboratory areas where biological and chemical hazards are present.
- Minimal travel may be required
Relocation support available
Work Location Assignment:On Premise
Last date to apply: 10/18/22
Relocation assistance may be available based on business needs and/or eligibility.
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.
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.
Continuous Imprv and Proj Mgmt