Product Labeling Manager (QA)
Company: Advanced Clinical
Location: San Francisco
Posted on: February 25, 2021
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Job Description:
Product Labeling Manager (QA)Location: San Francisco, CA***
MINIMUM 6+ years' in biopharmaceutical (and some med-device)
industry is REQUIRED ****** MINIMUM 4+ years of direct Product
Labeling experience is REQUIRED ***RESPONSIBILITIES* Overseeing the
execution of the processes related to the development of and
modifications to the Company's Product labeling.* Ensuring changes
to Product labeling are properly documented and justified.* Working
closely with departments to identify Product Labeling requirements
that meet global regulatory requirements and Company timelines in
an effective and efficient manner.* Evaluating policies and
procedures for cross-functional and global harmonization. *
Planning, organizing and prioritizing work activities, sets clear
goals and objectives for tasks by developing realistic and
effective plans of action that communicate and coordinate Product
labeling and documentation approvals.* Interacting with internal
multidisciplinary team members, CROs and external contract
packaging/labeling/distributors and other service providers, to
support commercial and clinical trials globally. * Ensuring that
company's product labeling release process meets all written
procedures and global regulatory requirements.* Reviewing and
approving of label proofs, pre and post executed Batch Records for
all phases of development and commercial timelines.* Being
responsible for the creation of and modification to product
labeling following internal procedures and ensuring labeling
content is compliant with global regulatory requirements.*
Coordinating Product labeling review and approvals* Aiding in
development and documentation of business processes to support
product labeling.* Participating in audit related activities, gap
assessments, and response/mitigation activities* Representing the
labeling team as necessary as the SME in cross-functional project
team meetings.* Managing key internal and external partnerships,
including internal customers and contract service providers*
Assessing new clinical programs for Product Labeling requirements*
Identifying and communicating quality or compliance risks
associated with Product labeling and determination appropriate plan
to address risks.* Developing, implementing and maintaining
business processes and SOPs supporting Product labeling.* Working
with the Program Teams to develop and maintain Product labeling for
clinical trials with appropriate risk assessment and mitigation to
track and oversee development and execution of Product labeling.*
Overseeing review and approval of Product labeling.* Assuring
Quality Management is informed of any potential compliance issue
with Product labeling and other labeling service providers*
Participating and/or overseeing the disposition of Product labeling
and finished goodQUALIFICATIONS * Minimum 6+ years' in
pharmaceutical and some medical devices* Minimum 4+ years of direct
Product Labeling experience in regulated industry (pharma/biotech
and medical device)* Strong knowledge of cGMP regulations,
practices and trends pertaining to pharmaceutical product
development, manufacturing, testing, and clinical
operationsEDUCATION* B.A./B.S. in any Life Science discipline is
REQUIRED
Keywords: Advanced Clinical, San Francisco , Product Labeling Manager (QA), Executive , San Francisco, California
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