Manager, Quality Operations (On-site - Acton, MA.)

Reporting directly to the Director of Quality Operations, the Manager, Quality Operations provides an oversight of a variety of analytical functions that occur in the QC department supporting validation, testing, and reporting of incoming, in-process, and post sterile release. This role also plays a critical role in managing control of product flow from through the supply chain, especially as it relates to holds and non-conforming products.  This role also ensures activities occur in an efficient and cGMP compliant manner. The role will have formal people management responsibilities.

Responsibilities:

• People Manager - Responsible for the day-to-day management of a group of employees.

  • Performance management: Monitor employee performance, provide feedback, and address performance issues

  • Goal setting: Set goals for the team and ensure employees understand how their work contributes to company objectives

  • Team development: Recruit, train, and develop new employees who fit the company's culture

  • Employee engagement: Create a supportive and inclusive work environment
     

• Manages various QC/QA program(s)/processes within the department (training, sample management, data review and reporting) and serves as subject matter expert (SME).  Primary focus is on warehouse and distribution along with Incoming and QC activities at 50 Nagog site.

• Ensures post-sterile product is not released for distribution until all Device Master Record requirements have been met.

• Ensures appropriate product control throughout the supply chain for USAM product and collaborates with other quality leaders globally on the same.

• Coordinates and facilities QC/QA activities to meet commitments on-time

• Ensure QC/QA personnel have appropriate training and competency

• Assist in troubleshooting of test methods and/or equipment as required

• Authors, review, and/or approves data, SOPs, COAs, DHRs and other documents as needed

• Monitor, track publish and report QC/QA metrics (NCMR, CAPA, etc.) at the Operations meetings. As necessary analyze QC/QA metrics to identify trends and actions necessary to correct adverse trends

• Ensure all QC/QA records and DHR documentation adhere to cGMP/GDP expectations

• Leads compliance related teams working towards the goal of continuous improvement

• May be required to lead NCMR, OOT investigations/deviations and to identify corrective actions to prevent reoccurrence

• Integral part of 50 Nagog leadership and serves as QC/QA representative in cross-functional, cross-departmental working teams

• Participates in internal and external quality audits

• Perform other duties as assigned

Minimum Requirements:

• BS/BA degree required.

• Minimum of 8 years’ experience of relevant experience in Quality Control / Quality Assurance

• Minimum 2 years’ managerial experience

• Minimum 2 years’ experience in Operations Quality Management

Preferred Skills and Competencies:   

• Excellent interpersonal, verbal, and written communication skills

• Must possess strong leadership and analytical skills with team-focused attitude

• Experience leading or supporting FDA and ISO 13485 inspections preferred

• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities

• Ability to communicate and work effectively at multiple levels within the organization

• Advanced PC skill, word processing, spreadsheet, and database

Travel Requirements:

• As required as dictated by the needs of the business (up to 15%)

Physical Requirements:

• The Quality manager's physical requirements involve the ability to walk, stand, and occasionally bend or reach within an environmentally controlled production facility which includes frequently entering the cleanroom. Often spend long periods sitting at a computer while also being able to move around to inspect products or processes, which may include occasional lifting.

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite 

Additional Information:

The US base salary range for this full-time position is $108,075.00 - $162,112.50. Our salary ranges are determined by role, level, and location. The range