Skip to main content

This job has expired

You will need to login before you can apply for a job.

Quality Engineering Senior Program Manager

Employer
Pfizer
Location
Rocky Mount, North Carolina
Start date
May 19, 2022

View more

Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Bio NC, Best Places to Work

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, operations, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

In this role as Quality Engineering Senior Program Manager, you will lead Pfizer Rocky Mount’s dedicated and highly effective Quality Engineering Program Managers. As a leader of this team, you are responsible for activities to strengthen Quality Systems and support the continuous improvement process by providing technical support to various Rocky Mount Quality units. Your work will be relied on to drive execution of across site and laboratory compliance initiatives significant in size and scale, lead project teams or direct other program managers leading project teams, ensure efficient achievement of project deliverables and timeliness of project completion and report project stats, delays, roadblocks to senior leaders and process owners.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

  • Manage and develop a team of program managers with respect to daily activities as well as provides training and skill development to secure succession planning strategies.
  • 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
  • Prepare schedules for the execution of projects/programs and documents project team activities ensuring delivery to team commitments
  • Facilitate problem solving of issues and roadblocks through engaging the RM Quality Leadership in identified issues
  • Facilitate resolution and appropriate escalation of conflicts within the team and with other stakeholders to ensure project success
  • Ensure a robust process is developed by ensuring decision making is driven by quality needs and balances the delivery expectations of the business appropriately
  • Engage, influence, and coordinate all functions involved in the project; including senior leadership levels within and above the site.
  • Defining and recommending corrective and or preventive actions for investigation or audit observations
  • Act as subject matter expert during regulatory and customer audits of Rocky Mount
  • Where required, may initiate and own investigations associated with unexpected events in programs/projects
  • Partner with Corporate and site functional teams to identify and implement optimal system designs that manage systems, elevating Quality issues and driving corrective actions.
  • Manage metrics associated with Quality and Cultural Transformation to ensure understanding of changes and progress
  • Submit annual budget and capital requests for support assigned projects or compliance programs
  • Initiate and implement Quality improvement activities as appropriate to support laboratory and manufacturing process excellence and compliance
  • All other duties as assigned

QUALIFICATIONS

Must Have

  • Bachelor’s degree required with 5+ years of experience in the Pharmaceutical industry or relevant business experience
  • 3+ years of project/program management experience
  • 3+ years of leadership experience.
  • Experience with implementation of multi-site or large-scale process improvements.
  • Demonstrate ability to work/contribute in a team-based environment as a lead and a participant with exceptional interpersonal skills, adept problem-solving skills, and drive for results.
  • Thorough knowledge and understanding of pharmaceutical regulations and guidelines, including but not limited to cGMPs, GLPs, ICH, USP, FDA and other applicable industry guidelines
  • Understanding of management skills including, but not limited to managing up and across organizations, task delegation, scheduling and prioritization.
  • Able to interact with employees, customers and regulatory agencies over a wide range of knowledge base.
  • Ability to manage multiple activities and constantly change priorities.
  • Strong organizational, presentation, meeting facilitation and technical writing skills
  • Mastery of core computer software/systems (Word, Excel, Project Trackwise, etc.)
  • Strong critical thinking and problem-solving skills

Nice to Have

  • Bachelor’s degree in a science or engineering related discipline with knowledge of quality operations/laboratory processes preferred.
  • Program Management Professional Certification preferred
  • 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
  • Lean Sigma Greenbelt Certification

PHYSICAL/MENTAL REQUIREMENTS

  • 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

OTHER JOB DETAILS:

  • Relocation support available

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.

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.

Continuous Imprv and Proj Mgmt

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert