Manager, Quality Assurance & Regulatory Affairs

RR Donnelley • Houston, TX

7d

About The Position

The Manager – QA/RA oversees implementation, maintenance, and continuous improvement of the site Quality Management System (QMS) and regulatory affairs for assigned locations. The role works with site management and personnel to plan, develop, implement, and improve relevant QMS requirements and ensure sustainable compliance with customer, state, federal, and international regulatory requirements in highly regulated markets, including medical device and FDA-regulated manufacturing. The position leads quality teams and activities spanning food, medical device, and pharmaceutical manufacturing, and may manage Quality and Regulatory staff at more than one site.

Requirements

• Bachelor's degree in a technical or life sciences field.
• At least 5 years of related work experience, including team leadership experience.
• At least 3 years of medical device or pharmaceutical QA or RA experience.
• Advanced training or experience in ISO 13485:2016, ISO 14971:2019, and FDA QSR.
• Ability to understand and interpret federal regulations and company operating procedures as they apply to regulated product manufacturing.
• Ability to prioritize and multitask with minimal supervision.
• Knowledge of USDA Organic food manufacturing requirements.
• Knowledge of PC systems and Microsoft Office Suite, including Word and Excel.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience with ISO-class cleanrooms and qualification for sterile production.
• ISO Lead Auditor certification or ASQ Certified Auditor.
• Certification in ISO 13485.

Responsibilities

• Lead the maintenance and continual improvement of site QMS requirements and processes, including those for food, medical device, and pharmaceutical manufacturing.
• Manage Quality Engineers, Supervisors, Specialists, and Auditors.
• Manage software quality activities.
• Lead product release for medical devices.
• Guide sites on process validation strategies.
• Coordinate activities to maintain applicable quality system requirements, including ISO 13485:2016, ISO 9001:2015, ISO 14971, ISO 11137, EU MDR, and FDA QSR.
• Inform site management of significant or potentially significant quality issues and facilitate root cause analysis and corrective and preventive actions.
• Monitor and measure QMS processes, including quality objectives, CAPAs, NCMRs, and preventive actions.
• Work with customers and suppliers to develop and approve quality agreements.
• Implement a risk-based approach to the site QMS and operations.
• Manage quality plans for major changes and implementations.
• Lead the organization and implementation of new products.
• Manage cleanroom and environmental product controls, coordinating with the sterilization vendor.
• Oversee effective use and continued implementation of eQMS systems.
• Interact with customers and assist with quality-related responses to site RFPs and RFIs.
• Lead and manage the internal audit process.
• Provide leadership and direction to Quality Department employees.
• Ensure deviation investigations are appropriately investigated and recorded.
• Perform other duties and responsibilities as assigned.

Benefits

• Medical coverage
• Dental coverage
• Vision coverage
• Paid time off
• Disability insurance
• 401(k) with company match
• Life insurance
• Voluntary supplemental insurance coverages
• Parental leave
• Adoption assistance
• Tuition assistance
• Employer and partner discounts
• Depending on the role, participation in a bonus, commission, or incentive program may be included in total compensation.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager