Company: Mallinckrodt Pharmaceuticals
Posted on: January 25, 2023
Job TitleDirector, QualityRequisitionJR000012536 Director,
Quality (Open)LocationST-Madison - USA504Additional
LocationsMadison, WIJob DescriptionSummaryResponsible 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
- 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
- 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
- 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
- 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
- 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.Minimum RequirementsEducation / Experience / Skills:
- Bachelor's degree in scientific discipline required. - Masters
or PhD degree in related field preferred.
- Minimum of 15 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
- 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.Organizational
- Plant personnel - leading a diverse group of individuals
- Partner with the support functions such as human resources,
finance, procurement, EHS, corporate quality and performance
- BARDA, FDA, EMA, URP and other state and local health
- OSHA, EPA and other environmental, health, and safety
- Vendors and suppliersWorking Conditions:
- 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
Keywords: Mallinckrodt Pharmaceuticals, Madison , Director, Quality, Executive , Madison, Wisconsin
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