QA Manager, Aseptic Compliance

Employer
Pfizer
Location
Sanford, North Carolina, United States
Posted
Sep 12, 2020
Ref
4791384
Required Education
Bachelors Degree
Position Type
Full time
ROLE SUMMARY

This role will be the Manager Aseptic Compliance for Gene Therapy Operations in Sanford, NC.

This position will support the Microbial Control group and will be responsible for Aseptic Compliance activities associated with the Gene Therapy operations in Stage 1 and startup activities supporting Stage 2. Major responsibilities will include design and execution of the contamination control strategy, media fill program strategy, airflow visualization support and review, aseptic behavior program and training support.

The position will also be responsible for the following: PQS Adherence Oversight, understanding/applying emerging regulatory expectations, drafting responses for corporate/external inspections (e.g. MSQA, BOH inspections), planning and executing highly complex projects, conducting continuous improvement activities, interfacing with and representing the Sanford site in cross-departmental/cross-site/cross-network/cross-organization meetings/summits, and providing aseptic practice guidance/coaching.

Additional key responsibilities will be Quality Assurance approver of SOPs, protocols, investigations, risk assessments (facilitator and/or team member), etc. ensuring compliance with all current site, corporate and regulatory requirements.

ROLE RESPONSIBILITIES

Responsible for knowing, understanding and acting in accordance with Pfizer's values

System owner for the Pfizer Sanford Aseptic Behavior program (including scheduling, conducting observations, ensuring adherence to aseptic behavior expectations, metrics creation and tracking/reporting status; developing and driving continuous improvement).

System owner for the GTx Pfizer Sanford Media Fill Program; validation master planning; defining worst-case conditions; intervention risk assessments.

Providing regulatory surveillance for emerging regulatory requirements and providing GTx Pfizer Sanford oversight to ensure the area remains in compliance with site procedures, global regulatory agency requirements and Pfizer Quality Standards.

Facilitates/completes PQS assessments and leads gap remediations as needed.

Facilitates compliance gap assessments (RONA) and leads gap remediations as needed.

Coordinates and provides any Aseptic Behavior data for the Site Quality Review Team (SQRT) meetings.

Responsible for Aseptic Behavior/Practices education (defines training requirements, metrics, tracks and reports site status); provides guidance/coaching; curriculum development.

Assessing existing situations and suggesting improvements in the Quality Systems to increase compliance throughout the facility/laboratory. Plans and leads highly complex projects to ensure their timely completion.

Interfaces with other parts of the organization such as Global Compliance Division, Global Quality Operations groups, Regulatory Affairs, and Pfizer Research and development groups.

QUALIFICATIONS:

8 -10 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field ( Must have direct drug product experience, aseptic experience)

5 -7 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a MS Degree in Science/related field ( Must have direct drug product experience, aseptic experience)

0 -1 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a Ph. D in Science/related field ( Must have direct drug product experience, aseptic experience)

Individual would primarily interact with the site Microbial Control and EM Sr. Manager, Quality Systems & Compliance Managers, GTx Quality Team Leads, Verification Team, GTx Operations (Directors and Leads), other Pfizer Sanford departments, other Pfizer PGS sites, and Pfizer research and development groups.

This position has no supervisory responsibilities but is expected to mentor / train colleagues.

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

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.

  • Last Date to Apply for Job: 18 September, 2020
  • Eligible for Relocation Package

Eligible for Employee Referral Bonus

Sunshine Act

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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.

Quality Assurance and Control