Position SummaryThe Quality Assurance Product Manager coordinates Quality Assurance operations for assigned products and customers and serves as the analytical and technical QA resident expert. This role supports departmental strategic goals, promotes the highest standards of quality and regulatory compliance, and serves as the primary quality liaison between Woodstock Sterile Solutions, customers, and internal partner organizations.
The Quality Assurance Product Manager provides world-class customer service with integrity, maintains strong client partnerships, and coordinates quality-system activities across the site to support audit readiness, timely issue resolution, and compliant manufacturing operations.
Key Responsibilities- Serve as the primary quality liaison for clients and internal customers and become the subject matter expert for assigned products, processes, and requirements.
- Support New Product Development activities for products and processes without a designated QA Customer Service representative.
- Coordinate and/or lead regulatory audit backroom activities and support in-room audit activities as appropriate.
- Co-host and support client audits and conduct or support site internal audits.
- Maintain systems and procedures that monitor Quality System health and support continuous audit readiness for client manufacturing areas.
- Perform statistical analyses and provide routine quality metrics to management.
- Develop and maintain client partnerships to ensure alignment, consensus, and effective issue resolution.
- Coordinate internal QA functions with customers and Woodstock Sterile Solutions departments, including investigation closure, change-control review and approval, audit-task coordination, corrections, evaluations, and effectiveness checks.
- Maintain client data sets, metrics, trackers, business-review materials, and updates to quality leadership teams.
- Interface with Operations and Customer Service to communicate requirements and maintain partnerships supporting third-party manufacturing operations.
- Coordinate key quality systems, including customer complaints, change control, inventory control, batch records, and other quality functions related to assigned products and clients.
- Support Quality Compliance during FDA and other agency inspections, customer audits, and internal audits.
- Interface with site departments to ensure compliance with SOPs and cGMPs through process observation and continuous improvement initiatives.
- Author client Annual Product Reviews and ensure timely review and approval.
- Identify, evaluate, and manage risk to ensure product quality and communicate risk policies and processes throughout the organization.
- Maintain the effectiveness of Quality System components relevant to the position and perform other duties as assigned.
QualificationsEducation- Bachelor's degree in a pharmaceutical-applicable field, such as Science, Biology, Chemistry, Health Administration, or Engineering.
Experience- Five or more years of experience in pharmaceutical quality and/or regulatory functions, or seven or more years in a regulated industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, and compliance activities.
- Experience working with third-party contract manufacturing in the pharmaceutical industry preferred.
- Demonstrated ability to influence others outside the incumbent's department; experience leading direct or indirect personnel preferred.
Knowledge & Skills- Strong communication skills across internal organizations, clients, and regulatory agencies.
- Ability to work independently with sound organizational skills and strong documentation practices.
- Knowledge of auditing principles and the ability to evaluate manufacturing and support functions for customer and regulatory audit readiness.
- Self-motivated, collaborative, receptive to feedback, and able to communicate opinions and feedback directly.
- Knowledge of quality, regulatory, and legal standards, including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, and FDA requirements.
- Knowledge of Quality Systems, SOP creation and control, and computerized-system validation principles under 21 CFR Part 11.
- Proficiency with Microsoft Word, Excel, and PowerPoint; experience with MasterControl preferred.
- Ability to read, reason, and solve problems in real time within an aseptic manufacturing environment.
- Ability to train others and read, write, and speak clear English.
Physical Requirements & Work Environment- Ability to enter manufacturing areas requiring full gowning and stand for extended periods in cleanroom or warehouse environments.
- Frequent sitting, standing, walking, reading, computer use, reaching, talking, writing, and listening.
- Occasional bending, grasping, carrying, stooping, kneeling, and crouching.
- Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds.
- Fast-paced, performance-driven, customer-focused, collaborative, and inclusive work environment.
Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
