Company: Germer International
Location: Cherry Hill
Posted on: April 3, 2021
Director, Quality Assurance & Quality Control Responsible for
the administration of Quality Assurance systems related to
monitoring of in-process production processes; release testing of
incoming components and raw materials, review and approval of
investigations and validation protocols and final reports.
Responsible for the QA oversight of all QA Documentation and GMP
Training of the facility. Responsible for QA and QC oversight of
production and laboratories activities, assuring that products are
manufactured in compliance with cGMP, USP, FDA, EU guidelines and
CFR 820 requirements for combination products and processes.
Responsible for the final batch record review and final lot
disposition. In the absence of the Sr. Director of Quality &
Technical Affairs, assumes responsibilities for daily functional
activities of the QA/QC division. Supervisory responsibilities
include supervision of (2) QC Managers (1) Quality Assurance &
Sterility Assurance Manager for Operations In-Process QA, QA
Incoming Components receipt and release, Sterility Assurance &
Aseptic Technique and batch record review and release; (1) Quality
Engineering Manager that oversee the review and approval of
investigations, validation protocols, final reports, change
controls and Particle Action Limit program; (1) QA Documentation
Manager for batch record issuance, SOPs, change controls and the
site's GMP Training Program. Supervisory responsibilities for
directing and managing people and systems that assure product
quality and conformance to regulations and company policies. Lead
efforts toward continuous Quality improvements.
- Directs the Incoming QA and QA Operations departments.
- Identify and direct activities to ensure compliance to FDA
regulation and other State, Federal and International regulatory
- Participates and assists with developing/deploying of various
quality systems (e.g. MIR metric review, CAPA review) that ensure
products conform to defined requirements.
- Ensures that QA perspective for engineering reports (FRSs,
commissioning documents), validation protocols and final reports
including but not limited to equipment, process/product protocols
- Periodically reviews the suitability and effectiveness of the
- Provides QA oversight of the entire Manufacturing site.
- Provides QA oversight for the required guidelines for CFR 820
to ensure that the combination products and processes for the
prefilled syringe (PFS) and intravenous bag (IV Bag) platforms are
manufactured and monitored within the required guidelines.
- Provides QA guidance for the Analytical and Product Technology
Transfer for products being developed in R&D to include input
for the manufacturing and processes required for the drug product
filled into vials, ampuls, PFS, IV bags and emulsions.
- Oversees development and implementation of standards, methods
and procedures for inspecting, testing and evaluating the
precision, accuracy and reliability of client company products, raw
materials and in-process intermediates.
- Develops budget and monitors expenditures.
- Makes recommendations for corrective action necessary to assure
conformity with quality specifications.
- Assures finished products conform to government and client
company standards and satisfies GMP regulations.
- Facilitates necessary changes to systems to assure that the
analytical operations, are always up to the level of FDA
- Interacts with customers and regulators concerning the quality
of products, systems, and processes.
- Identify and drive quality initiatives.
- Directs personnel responsible for establishing policies,
guidelines, and procedures, and makes final accept/ rework/reject
decisions on compounding, in-process filling, and
- Direct and implement the organization's quality improvement
plan in accordance with the mission statement and strategic goals
of the organization, federal and state laws and regulations, and
- Directs the activities of personnel responsible for developing
procedures (specifications and test methods) and making decisions
on release/rejection of all incoming components, labels, and
packaging materials including raw material sampling. Ensures that
incoming material issues with vendors are tracked and resolved, as
- Assumes responsibilities of final batch record review and final
product release and disposition.
- Lead and participate in cross-functional teams to drive
improvements in processes that impact compliance to regulations and
- Provide QA perspective and final approval for manufacturing
investigations. Assures timely review/completion of all
investigations. Assures adequate corrective action, commitment
tracking, and trending is completed for all investigations.
- Assumes responsibilities of daily functional activities and has
authority to make decisions for the QA/QC division in absence of
the Sr. Director, Quality & Technical Affairs. Represents QA/QC in
external and internal meetings.
- Actively participates on various project teams and committees
such as Operational Excellence, CAPA Review, Site Management,
R&D Product Transfers and Quality Council.
- Develops personnel, administers budget, plans for future
resource needs with regards to personnel, equipment, and
- Assists with FDA and other regulatory agencies' inspections and
pre/post approval inspections.
- Responsible for the biennial SOP review and the site's GMP
training metric, change control and timely issuance of commercial
and developmental batch records.
- Responsible for final approval of all change control activities
(e.g. equipment, facility, master batch record). Responsible for
final QA approval engineering design/developmental documents and
- Manage overall coaching, training, development and succession
planning for the department. Ensures that Performance Reviews are
completed in a timely manner, as well as development planning
- Bachelor of Science in a science. Advanced degree
- Minimum of 10 years' experience in Quality and/or Manufacturing
within FDA/other regulatory environments of parenteral
- Experience in manufacturing Injectables Quality Assurance
- Experience in manufacturing Injectables Quality Control
- Must possess a strong knowledge of quality systems for
parenteral drug products per CFR 210/211 and combination products
per CFR 820 requirements related to prefilled syringe and
intravenous bag manufacturing.
- Must have organizational skills and management skills. Must
possess strong leadership skills.
- Experience in sterile manufacturing of aseptically filled and
terminally sterilized processes, sterility assurance and
- Demonstrated ability to direct a department, oversee
- Must possess strong analytical and problem-solving skills. In
over 25 years of placing the right professionals in the right jobs,
Germer International has earned the trust of hundreds of
Pharmaceutical, Biotech, and Medical Device companies, attracting
the best qualified candidates. VEVA 14
1777 Sentry Parkway - Blue Bell PA 19422
Keywords: Germer International, Cherry Hill , Director QA/QC, Executive , Cherry Hill, New Jersey
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