Sr. Manager - Quality - Visual Inspection & Particulate Control
About The Position
The Sr. Manager - Quality - Visual Inspection & Particulate Control provides strategic and technical Quality leadership for manufacturing and laboratory quality systems, focusing on visual inspection and particulate matter control for injectable products. The role ensures that inspection programs, qualification and validation activities, particulate investigations, and related controls are scientifically sound, risk-based, well documented, and aligned with regulatory requirements, compendial expectations, and the company Quality Management System. The position provides Quality oversight of manual, semi-automated, and automated visual inspection programs; develops particulate control strategies; leads qualification, validation, and complex investigation activities; and collaborates across functions to improve process performance and reduce defects. It also supports regulatory inspections and audits and establishes quality metrics and trend analyses to identify emerging issues and sustain improvements.
Requirements
- Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences, or a related scientific or technical discipline.
- Typically 10+ years of progressive experience within pharmaceutical, biopharmaceutical, medical device, or other highly regulated manufacturing environments, including significant Quality leadership responsibilities.
- Demonstrated expertise in visual inspection programs for injectable or sterile products, including inspection strategy, defect classification, qualification programs, and performance monitoring.
- Experience leading complex investigations, risk assessments, corrective and preventive action (CAPA) programs, validation activities, and regulatory inspection responses.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable compendial requirements, including USP <790> and USP <1790>.
- Experience making science-based quality decisions involving product disposition, compliance risk management, and quality system effectiveness.
- Strong communication, collaboration, and influencing skills, with the ability to build alignment across functions while maintaining independent quality judgment.
- Leadership experience through direct people leadership, matrix leadership, or technical leadership roles.
- Must be authorized to work for any employer in the U.S.; visa sponsorship or transfer is unavailable.
Nice To Haves
- Advanced degree in Pharmaceutical Sciences, Chemistry, Microbiology, Engineering, or a related discipline.
- Experience supporting commercial sterile manufacturing operations for injectable pharmaceutical products.
- Expertise in particulate characterization techniques, defect identification, and contamination control strategies.
- Experience implementing continuous improvement initiatives that improve inspection effectiveness, defect prevention, and process capability.
- Experience interacting directly with the FDA, Health Canada, EMA, or other global regulatory agencies.
- Certification or advanced training in Quality Risk Management, Lean Six Sigma, or related continuous improvement methodologies.
Responsibilities
- Lead Quality oversight for manual, semi-automated, and automated visual inspection programs, ensuring processes remain effective, compliant, and aligned with patient safety expectations.
- Develop and maintain risk-based particulate control strategies to strengthen defect prevention, improve manufacturing controls, and reduce product quality risks.
- Provide technical leadership for qualification and validation activities related to visual inspection systems, ensuring studies are scientifically sound, appropriately designed, and fully documented.
- Direct complex investigations involving visible particulate matter, inspection trends, and product quality events, driving objective root cause analysis and effective corrective actions.
- Partner with Operations, Engineering, Laboratory, and Quality teams to identify process improvement, defect reduction, and inspection performance opportunities.
- Support regulatory inspections, customer audits, and health authority interactions with expertise, documentation, and responses related to visual inspection and particulate control programs.
- Establish and monitor quality performance metrics, trend analyses, and risk indicators to identify emerging issues and ensure sustainable improvements.
Benefits
- Medical and dental coverage starting on day one.
- Basic life, accident, short-term and long-term disability, and business travel accident insurance.
- Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
- 401(k) Retirement Savings Plan with employee contributions and company matching.
- Flexible Spending Accounts.
- Educational assistance programs.
- Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
- Family and medical leaves of absence and paid parental leave.
- Commuting benefits.
- Employee Discount Program.
- Employee Assistance Program (EAP).
- Childcare benefits.
- May be eligible for discretionary bonuses.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
