The QA Product Manager (Sterile Products) is responsible for ensuring the quality and compliance of sterile 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, and drive continuous improvement initiatives to ensure the safety and sterility of our products.

The following job duties are not all-inclusive and additional responsibilities may be added to the role as needed. The duties and responsibilities listed are intended to provide a general overview of the position and may change over time based on the needs of the organization.

• Lead Quality Assurance efforts for sterile pharmaceutical products manufactured by third-party manufacturers.
• Develop and implement Quality Assurance strategies, policies, and procedures specific to third-party manufacturing, focusing on sterility assurance and product quality.
• Collaborate with cross-functional teams to establish and maintain strong quality systems and agreements with third-party manufacturers, ensuring compliance with regulatory requirements
• Conduct rigorous assessments and audits of potential and existing third-party manufacturers to ensure they meet our quality standards and regulatory requirements.
• Define and communicate product specifications, sterility assurance practices, and acceptance criteria to third-party manufacturers.
• Oversee and provide guidance on the design and execution of validation activities related to sterile manufacturing processes, including process validation and sterilization validation.
• 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.

Minimum Job Requirements

Qualifications

• 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 a focus on sterile products and third-party manufacturing.
• Excellent understanding of sterile manufacturing processes, sterility assurance practices, equipment lifecycle management and validation requirements.
• Strong knowledge of regulatory requirements and guidelines, such as FDA, EMA, MHRA, PIC/S, ICH, and sterility assurance standards.
• Experience working with third-party manufacturers and managing quality assurance activities related to sterile products.
• 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.

Competencies

• 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.).

Other Requirements

• This is an individual contributor role and has no/some decision-making authority.
• Professional certifications in Quality Assurance (e.g., ASQ Certified Quality Auditor, Certified Quality Manager) are a plus.
• Ability and willingness to travel approximately 25% of the year both domestically (15%) and internationally (10%).

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

Additional Information

The base salary range for this full-time position is $120,000 - $150,000. Individual pay is determined by several factors, which include but are not limited to: job-related skills, experience, and relevant education or training. The range does not include the comprehensive benefits, bonus, long-term incentive, applicable allowances, or any additional compensation that may be associated with this role. 

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race, color, religion, sex (including pregnancy), marital status, national origin, age, ancestry, citizenship, disability, genetic information, status as a disabled veteran, a recently separated veteran, Active Duty Wartime or Campaign Badge Veterans, and Armed Forces Service Medal Veterans, or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal, state, and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are, in fact, non-discriminatory.

If you are qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request accommodations by calling 973-307-3550 or by sending an email to ShionogiHR@shionogi.com.