Associate Director Quality

• Acts as the Management Representative for Quality
• Manages the Quality organization in a mid to large size plant
• Manages the batch review and release activities
• Fulfills the role of PRRC
• Directs large programs and departments in support of division or company-wide initiatives
• Develops and deploys the quality systems
• Understands and deploys processes to assure conformance to regulations
• Periodically reviews the suitability and effectiveness of the quality system with executive management
• Drives continuous improvement of processes and systems
• Assesses and advises senior management concerning acquisition targets
• Interacts frequently with all levels of internal management
• Manages interactions with customers and regulators
• Responsible for adherence to specifications and procedures
• Develop budget for quality organization and ensures adherence to the budget
• Manages overall coaching, training, development and succession plans for the team

• In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
• Strong leadership skills and demonstrated success in managing a large team
• Strong analytical, problem solving, and decision-making skills
• Excellent verbal and written communication skills
• Success working with multifunctional, global teams
• Excellent interpersonal/communication/influencing/negotiation skills required
• Extensive working knowledge of applicable quality and regulatory standards and regulations
• Experience in risk management, validation, analytics and microbiology, within a GMP environment
• Quality expertise on tech transfer
• Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment
• BS in science or engineering
• Minimum of 10 years of experience in Quality, Manufacturing or related field in the medical products industry
• 7 years management experience

Advanced degree helpful

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• Medical and dental coverage that start on day one
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits