Quality Assurance Manager, Operations

Purpose of Position:

Manage and maintain the execution of Quality and Regulatory operations at Life Sciences manufacturing, sterilization, and distribution locations; including all related activities to ensure that the products meet applicable requirements. Promote continuous improvement in customer satisfaction through inter-department communication, internal manufacturing specification understanding, sharing information, leadership of quality improvement projects. This role is focused on delivery the highest quality product in the market at the lowest possible price by rigorous adherence to manufacturing requirements and effectively implementing cost of quality culture. 

Key Responsibilities:

• Manage and provide leadership to the quality departments within LS manufacturing locations to ensure products meet both customer expectations and all applicable regulatory requirements.
• Ensure sites have effectively implemented the division-level Quality System requirements; ISO 9001, ISO 17025, ISO 13485, and 21 CFR Part 820, as needed.
• Support receivership of the new product development process including plant resourcing, supplier/customer quality issue resolution for product realization.
• Drive department or regional program/ project portfolio to meet immediate and ongoing business needs including ongoing management of applicable resources.
• Frequently and effectively interact and resolve issues with peer-QARA leadership (i.e., team members) with little to no involvement from outside parties.

• Act as QARA integration point with manufacturing (Ops and engineering) for shared objectives and priorities.

• Effectively communicate impactful manufacturing issues/ actions with QARA peers to ensure all product, compliance, and customer needs are met. 
• Coach and develop all direct employees to ensure they can effectively oversee production of conforming product in the spirit of customer obsession.
• Develop methods/metrics to evaluate and continuously improve process capability and product control plans; execute via collaboration with plant and division engineering.

• Provide oversight and ensure appropriate execution of the nonconforming materials program; ensure only highest quality parts are shipped to the customer using risk-based principles.  

Education Required: 

Bachelor’s Degree with technical discipline (e.g., Biology, Chemistry, Engineering, etc.) required; strong preference for candidates with a MBA or MS degree.


Experience and Skills

Minimum of 12 years’ experience in Quality Assurance or Regulatory with a minimum of 7 years in medical device/ biotech/ pharma.

Minimum of 5 years’ experience working in an active manufacturing environment.

Experience operating within regulated quality systems that are compliant with ISO 9001, ISO 13485, ISO 17025, and/ or 21 CFR Part 820, 210/211.

Demonstrated project management experience, including leading large-scale and/or multiple concurrent initiatives.

Minimum of 2 years’ experience managing operations across multiple manufacturing sites, with the ability to effectively prioritize competing, dynamic business needs.

Progressive leadership experience in operations, quality, and/or engineering, including supervisory or departmental leadership roles.

Proven ability to lead teams through continuous improvement initiatives, step‑change performance improvements, innovation, technical capability expansion, and organizational or work‑process change.

Strong communication, tactical thinking, and influencing skills, with the ability to effectively engage stakeholders at all levels, including customers and executive leadership.

High sense of urgency and accountability, with demonstrated success driving cross‑functional problem resolution and decision‑making related to manufacturing product quality; Conflict‑resolution experience preferred.

Demonstrated track record of developing talent and building strong pipeline talent, focused specifically on effectively demonstrating leadership principles that are aligned with organizational values.

Experience coordinating activities within functional areas and collaborating cross‑functionally to achieve business objectives.