Director, Quality Assurance
Company: QUVA PHARMA
Posted on: April 6, 2021
Responsible for managing all Quality Assurance and Quality
Systems departments supporting all aspects of compounding sterile
pharmaceuticals and regulatory compliance within the facility.
Operates within the legal and regulatory compliance, producing a
quality product. Operates the area as the supervisor over the QA
and QS staff, coordinating roles & responsibilities and projects.
Responsibilities may include:
- Supervises QA & QS managers by providing learning and
development where appropriate.
- Ability to make Quality decisions related to maintenance of
aseptic conditions within clean rooms with a focus on Sterility
Assurance during manufacturing operations.
- Manages the on-time release of batches.
- Manages the on-time initiation and closure of Deviations /
Investigations, CAPAs, Change Controls with thorough & standardized
- Manages others to ensure appropriate SOPs and training
documents are in place & effective.
- Manages others to ensure the design and maintenance of the
environmental monitoring program including environmental and
personnel monitoring are adequate and in place.
- Manages others to ensure QuVa quality standards are met at the
site so that processes are the same as other QuVa sites.
- Maintain compliance with FDA 503B and cGMP guidelines / state
and federal laws
- Prepares and submits weekly/monthly reports, prepares metrics
and trends data to identify and prioritize continuous improvement
- Manages others to maintain site documents supporting the
commercial manufacturing & release of sterile injectable
- Manages the design and implementation of site policies and
- Escalates to VP of Quality critical issues jeopardizing
manufacturing & release of a safe & effective product that meets
- Promptly communicates with Operations regarding complaints,
- Enforces applicable personnel policies and procedures
- Legally authorized to work in the job posting country
- Bachelors Degree in Life Science or other related field.
- Minimum 10 years prior experience in Quality Assurance / cGMP /
FDA regulated industry.
- Minimum 5 years of supervisory or management experience
- Experience with aseptic techniques and appropriate gowning
techniques supporting manufacturing of sterile injectable
- Technical writing and communication.
- Well versed in the compliance & quality requirements of 503B
pharmaceutical industry and cGMPs and have demonstrated strength in
problem solving and resolution.
- Strong interpersonal skills To be considered: In order to be
considered for this position you must complete the entire
application process, which includes answering all prescreening
questions and providing your eSignature on or before the
requisition closing date. Candidates for regular U.S. positions
must be a U.S. citizen or national, or an alien admitted as
permanent resident, refugee, asylee or temporary resident under 8
U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such
as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for
work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for
employment to all individuals regardless of race, color, age,
national origin, physical or mental disability, history of
disability, ancestry, citizenship status, political affiliation,
religion, gender, transgender, gender identity, marital status,
status as a parent, sexual orientation, veteran status, genetic
information or other factors prohibited by law, and to prohibit
harassment or retaliation based on any of these factors.
Keywords: QUVA PHARMA, Bethlehem , Director, Quality Assurance, Executive , Bloomsbury, Pennsylvania
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