QA Product Manager

Shionogi Inc.•Florham Park, NJ

3d•$120,000 - $150,000•Hybrid

About The Position

The QA Product Manager is responsible for ensuring the quality and compliance of pharmaceutical products (active pharmaceutical ingredients and/or drug products) manufactured by third-party contractors/suppliers (CMOs). This role involves collaborating with cross-functional teams (regional and global), including external manufacturers, Supply Chain, Regulatory Affairs, and Pharmaceutical Sciences, to establish robust quality systems, implement sterility assurance practices including effective contamination control strategies, and maintain adherence to regulatory guidelines. The QA Product Manager will lead quality assurance efforts, review and disposition batches, conduct audits, may and drive continuous improvement initiatives to ensure the safety and sterility of our products.

Requirements

Bachelor's degree in Life Sciences (Biology, Microbiology, Pharmacy, Pharmaceutical Sciences, Chemistry, or a related field). Advanced degree is desirable.
Minimum of five (5) years of experience in pharmaceutical Quality Assurance, with experience in third-party manufacturing. Sterile experience a plus.
Demonstrated ability to perform audits of third-party manufacturing suppliers (i.e., API and drug product manufacturers, packagers, testing laboratories, distributors/warehouses, etc.)
Strong project management skills, including the ability to prioritize tasks, meet deadlines, and manage multiple projects involving third-party manufacturers.
Excellent communication and interpersonal skills, with the ability to effectively communicate technical information to external partners and internal stakeholders.
Demonstrated ability to work on complex assignments in collaboration with various departments and analytical problem-solving ability.
Experience with quality management software and tools such as Veeva including demonstrated computer experience with MS Word, Excel, and Outlook.
Knowledge of pharmaceutical product development processes, supply chain management, and regulatory requirements for third-party manufacturing.
Familiarity with regulatory expectations for third-party manufacturing. Understanding the regulatory landscape and ability to navigate the regulatory requirements is a plus.
Experienced auditor, preferably in a cGMP environment.
Experience with coordinating cross-functional teams and driving projects related to third-party manufacturing.
Experience applying risk management principles and tools to assess and mitigate quality risks.
Knowledge of Pharmaceutical manufacturing and laboratory skills.
Knowledge of global pharmaceutical regulations (i.e., EMEA, MHRA, PMDA, Health Canada, etc.).
Ability and willingness to travel approximately 25% of the year both domestically (10-15%) and internationally (10-15%).
Must live a commutable distance to our US Corporate Headquarters in Florham Park, NJ. Office presence required at least 50% of the time per month

Nice To Haves

Professional certifications in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Manager) are a plus.

Responsibilities

Lead Quality Assurance efforts for pharmaceutical products manufactured by third-party manufacturers. These can range from non-sterile to sterile products.
Develop and Implement Quality Assurance strategies, policies, and procedures specific to third-party manufacturing, focusing on product quality.
Conduct rigorous assessments and audits of potential and existing third-party manufacturers to ensure they meet our quality standards and regulatory requirements.
Oversee and provide guidance on the design and execution of validation including sterilization validation when needed.
Provide technical guidance and support to third-party manufacturers regarding quality systems, sterility assurance practices, and regulatory compliance.
Collaborate with Regulatory Affairs teams to support product registrations, submissions, and regulatory inspections related to third-party manufacturing.
Resolve quality issues, including initiating internal and coordinating external product-related investigations, deviations, OOS/OOT investigations, CAPAs, change controls, and quality complaints related to the manufacturing, packaging, and testing of assigned products.
Performs batch record review and communicates any adverse findings to approved contract organizations. Performs final batch disposition.
Manage the development and communication of product specifications, sterility assurance practices, and acceptance criteria to third-party manufacturers.
Review and approve stability protocols and stability results for owned products.
Assist in drafting and negotiating Quality and Technical Agreements
Assembles and/or writes the Annual Product Review for assigned products.