This role will be the Manager QA, Environmental Control and
Aseptic Compliance in Sanford, NC.
This Individual Contributor position will support the Microbial
Control group and will be responsible for Environmental Control and
Aseptic Compliance activities associated with the manufacturing
operations in Sanford Vaccines and Gene Therapy programs. 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
meetings/summits, and providing aseptic practice
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.
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
System owner for the Pfizer Sanford Media Fill Program;
validation master planning; defining worst-case conditions;
intervention risk assessments.
System owner for the Pfizer Sanford Disinfectant Efficacy
program; defining worst-case conditions, disinfectant selection,
organism and surface evaluations
Providing regulatory surveillance for emerging regulatory
requirements and providing 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
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.
* 8 years minimum of manufacturing, quality or engineering
experience in the biotech or pharmaceutical industry with a BS/BA
Degree in Science/related field is required, OR * 5 years minimum
of manufacturing, quality or engineering experience in the biotech
or pharmaceutical industry with a MS Degree in Science/related
field is required, OR * Ph. D in Science/related field is required,
prior manufacturing, quality or engineering experience in the
biotech or pharmaceutical industry is preferred.
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a
time. Require working in an office setting where sitting and
computer usage would be typical.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT
Limited travel for the position; no more than 15% traveling.
Other Job Details:
* Last Date to Apply for Job: 5/10/2021 * Eligible for
Relocation Package * Eligible for Employee Referral Bonus
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.
Quality Assurance and Control