Job Description
About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.
Job Summary:
The Sr. Manager, Quality Operations is responsible for managing the Quality Product Release and Quality Operations teams to ensure that manufactured and packaged products meet current GMP requirements, company policies, and regulatory expectations. This position provides leadership and technical oversight for batch record review, product release, in-process quality activities, and compliance of shop-floor operations in manufacturing and packaging as well as logistics/warehouse oversight. The role is also accountable for coaching and developing supervisory and professional staff, driving continuous improvement of quality systems, and partnering cross-functionally to ensure on-time product availability and sustained regulatory compliance.
Key Responsibilities:
Leadership and Oversight of Quality Operations
- Manage the Supervisor, Quality Operations and the QA Product Release team to ensure effective execution of day-to-day quality activities supporting manufacturing, packaging, and R&D operations.
- Provide oversight for on-the-floor QA presence, in-process checks, and real-time issue resolution to ensure cGMP compliance and timely production support.
- Review and approve shop-floor documentation, batch records, and logbooks to ensure accuracy and traceability.
- Ensure alignment of quality operations with production schedules and inventory requirements through coordination with Planning and Scheduling.
- Support investigations and CAPAs as needed to resolve non-conformances and drive root cause elimination.
- Oversee retention sample and storage programs and ensure compliance with internal and regulatory requirements.
Product Release and Compliance Management
- Oversee review and final disposition of manufactured and packaged drug products, including Certificates of Compliance and Analysis.
- Ensure timely release of materials and products by coordinating with Quality Control, Manufacturing, and Logistics.
- Ensure that release decisions are supported by complete, accurate, and compliant documentation.
- Participate in regulatory and client audits to represent the Product Release and Operations functions.
- Drive compliance and readiness for internal and external inspections.
Strategic and Continuous Improvement
- Implement metrics and trending tools for cycle time, documentation accuracy, and on-time release performance.
- Partner with Quality Systems and Manufacturing Leadership to identify process inefficiencies and drive CAPA effectiveness and quality culture improvement.
- Support development and maintenance of SOPs, forms, and training materials applicable to Quality Operations and Product Release.
- Contribute to the Annual Product Review and Quality Management Review by providing data and trend analysis.
People Management and Development
- Recruit, train, develop, and manage the performance of direct reports to build a high-performing team.
- Ensure all staff maintain current training and qualification status for their assigned tasks.
- Provide ongoing feedback, coaching, and formal performance reviews.
- Promote cross-training and career development within the Quality Operations organization.
- Ensure adherence to the Company’s Business Ethics, Compliance Program, and Health and Safety policies.
Collaboration and Communication
- Serve as the primary Quality liaison between Operations, Engineering, Planning, and Supply Chain to facilitate efficient product flow.
- Provide timely communication to senior management regarding release status, quality risks, and resource needs.
- Participate in cross-functional meetings to align Quality priorities with business objectives.
Education:
- Bachelor of Science or Engineering Degree.
Knowledge, Skills and Abilities:
- Strong organizational, interpersonal and communication skills
- Proven ability to lead and motivate subordinates
- Extensive knowledge and understanding of GMP regulations.
- Excellent problem-solving and troubleshooting abilities
- Well-developed interpersonal and team-building skills.
- Customer-service oriented.
- Proven organizational, time management, and project management skills.
- Excellent oral and written English communication skills.
Experience:
- Minimum 7-10 years of experience in a GMP-regulated industry, 3 years of which has been spent in a Quality Control Unit.
- Minimum 5 years of management experience, preferably in the pharmaceutical or equivalent industry.
Benefits:
- Aveva Drug Delivery Systems and DifGen Pharmaceuticals provides a comprehensive benefits plan
- Medical/Dental/Vision Insurance
- Paid Time Off
- 401k with employer match
- Paid Holidays and Floating Holiday
Equal Opportunity Employer