Job Description

Responsible for overseeing the overall Quality function of the Stratatech organization.  Creates, implements, prioritizes, and communicates the facilities’ Quality strategy and its Quality programs, aligning same with Mallinckrodt Corporate Quality Strategy & Programs.  Promotes recognition of Quality programs throughout the organization.  Responsible for translating the company’s (Mallinckrodt’s) Quality strategy into tactical policies, processes, and procedures to meet overall regulatory and legislative standards.

Essential Functions

• Leads the development and maintenance of facility Quality Management System and associated procedures and authorizes the implementation of these, ensuring alignment to Mallinckrodt company policies.
• Provides general direction to and review of the Quality function within the organization.
• Responsible for site audit readiness and ensures adoption and compliance to all applicable regulatory standard requirements, guidance and best practices applicable to the Stratatech product family.
• Leading all external regulatory inspections of the Stratatech business, coordinating own and peer departments in preparation and support of such assessments.
• Directs all Quality related activities within the organization through functional managers in Quality Assurance and Quality Control.
• Full Quality Operational oversight and responsibility for the Stratatech product groups and facilities operation.
• Identifies and implements creative solutions to abstract problems across the Quality function of the organization.  Identifies and evaluates fundamental issues and potential areas of improvement through assessment of tangible and intangible variables.
• Actively supports senior leadership in the development and formulation of long and short-range planning, policies, programs and objectives.  Participates in corporate development of methods, techniques, and evaluation criteria for projects, programs, and people.
• Responsible for product quality oversight, management and escalation from a Quality perspective, to senior leadership.
• Ensures own and business awareness of regulatory guidelines and guidance documents; including current Good Manufacturing Practices and new technology affecting the Quality function to ensure compliance with regulatory and corporate quality policies, and the goals of the company.
• Develop, execute and maintain facility Quality Scorecard / Dashboard, ensuring performance levels attained deliver on expected target goals and demonstrate best in class performance. Participate in all Stratatech and Mallinckrodt reviews and business forums ensuring the Quality System requirements of the Stratatech product groups are effectively represented at all times.
• Partner with Regulatory Affairs, Clinical, Clinical Quality Compliance, Process Development, Global Quality Systems and Manufacturing departments to ensure coordination, integration, and execution of Quality activities across all departments.
• Responsible for the identification, acquisition, development and retention of high performing Quality Talent, ensuring adequate and competent Quality resources are present as needed.
• Perform Quality related activities periodically as necessitated.

Education / Experience / Skills:

• Bachelor’s degree in scientific discipline required.  Masters or PhD degree in related field preferred.
• Minimum of 10 years relevant quality systems experience in a pharmaceutical, biotechnical or medical device environment.
• Demonstrated track record in Commercial product environment, experience in the Clinical / Pre-Clinical Phase preferred.

Competencies:

• Proven Quality Management System development and execution experience in a Biologics environment, including regulatory agency engagement for inspection readiness & execution.
• Experience of working with BARDA supported projects seen as a preferred competency / capability.
• Effective people leadership track record inclusive of succession planning and people development.
• Demonstrated results in the qualification of Biologic products development & manufacturing from a Quality perspective. Exhibiting strong collaboration skills.
• Excellent interpersonal, verbal, and written communication skills, with the ability to clearly and effectively present complex and technical materials to internal and external audiences.
• Proven ability to effectively communicate and interact with individuals throughout all levels of an organization; including, executive level management.

Internal Contacts:

• Plant personnel – leading a diverse group of individuals
• Partner with the support functions such as human resources, finance, procurement, EHS, corporate quality and performance excellence

External Contacts:

• BARDA, FDA, EMA, URP and other state and local health agencies
• OSHA, EPA and other environmental, health, and safety agencies
• Vendors and suppliers

• On-site at Stratatech facility on routine basis for interactions with site personnel
• Position will work both manufacturing plant environment and in an office environment.
• Occasional travel (5-10%) may be required
• Must be able to wear the required Personal Protective Equipment (PPE) out on the plant site as deemed necessary by EH&S.

How to Apply

Job Categories: Equal Opportunities. Job Types: Full-Time. Salaries: 100,000 and above.

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