Product Labeling Manager (QA)

Company: Advanced Clinical
Location: San Francisco
Posted on: February 25, 2021

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