SanFranRecruiter Since 2001
the smart solution for San Francisco jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Social Media Manager
Description: Looking for someone who has office skills, who is willing to learn new software, and who knows how to use social media.Bilingual workers encouraged to
Company: Express Employment Professionals - San Rafael
Location: San Rafael
Posted on: 03/3/2021

Director of Supply Chain and Planning
Description: Home Director of Supply Chain and Planning The Director of Supply Chain and Planning will bring strong LEAN manufacturing leadership and expertise to help drive La Tourangelle's oil processing and packaging (more...)
Company: La Tourangelle
Location: Woodland
Posted on: 03/3/2021

Account Manager - Grocery/Merchandising
Description: br br br br br THIS IS A PART TIME POSITION br SUMMARY: br The Account Manager - Grocery/Merchandising will work in Natural Food and Specialty Retailers. This candidate will develop relationships (more...)
Company: Dirty Hands LLC
Location: Santa Cruz
Posted on: 03/3/2021

Manager of Care Coordination RN
Description: Our organization is moving to a virtual recruitment process until further notice in response to COVID-19 novel coronavirus disease . Our virtual recruitment process may include telephone/video interviews (more...)
Company: Dignity Health
Location: Santa Cruz
Posted on: 03/3/2021

Director-Information Security - IT Security CISO - Full Time - 8 Hour - Days*
Description: Director-Information Security - IT Security CISO - Full Time - 8 Hour - Days Job Description: Establishes, implements, monitors, and enforces information security policies and standards enterprise wide. (more...)
Company: John Muir Health
Location: Walnut Creek
Posted on: 03/3/2021

Branch Manager
Description: Meet North American Title br br North American Title Company NATC is a seasoned Real Estate settlement company with over 60 years of expertise. Through its family companies - North American Title (more...)
Company: States Title
Location: Walnut Creek
Posted on: 03/3/2021

Retail Store Manager - Novato
Description: About Pet Food Express br br Pet Food Express is the best place to shop for pet supplies - and it's all because of the people who work here. Sure, we have better products and more convenient services. (more...)
Company: Pet Food Express
Location: Novato
Posted on: 03/3/2021

Chief Operating Officer
Description: Under direction of the Chief Executive Officer, the Chief Operating Officer COO is responsible for the efficiency and effectiveness of the Center's operations, devoting
Company: Petaluma Health Center
Location: Petaluma
Posted on: 03/3/2021

Director Demand Generation
Description: Job Overview br Got strong expertise and experience in the focused discipline of Demand Gen Marketing for B2B SaaS Built DG programs from ground-up successfully - and then evolved them over multiple (more...)
Company: Flosum
Location: San Ramon
Posted on: 03/3/2021

Senior Compliance Manager / Compliance Manager
Description: Senior Compliance Manager / Compliance Manager At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do.--To (more...)
Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: 03/3/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Francisco RSS job feeds