Mgr Quality

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

The position provides Quality oversight and support for Webster Groves manufacturing facility. The position will provide leadership and support for continued operation of the facility. The oversight includes signature authority, with responsibility for escalating high risk issues to management. The position is responsible for decisions relating to quality and project actions. The position is responsible for project decisions, risk identification, risk mitigation and cross-functional support with entire team (operations, regulatory affairs, science and technology, etc...). The main result of the incumbent is to ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products as well as projects such as tech transfer, new product introductions and inspection readiness.

ESSENTIAL FUNCTIONS:

• Provide leadership and support for the cGMP facility
• Provide QA oversight, including but not limited to:
  • Change management
  • Investigations (process, complaint, and laboratory)
  • Product release
  • In process controls
  • Annual Product Review
  • Master documents (batch records, methods, labels, etc...)
  • Facility/Equipment Qualification and validation (process/cleaning)
  • Stability data review / stability coordination
  • CAPA
• Develop and execute validation and compliance strategy for Webster Groves commercial plant
• Conducts/Coordinates supplier audits and supports audits as part of the audit team, as needed
• Identify, develop and execute project plan and timelines to achieve desired results
• Liaise with other intracompany facilities (Hobart, STLP) for laboratory testing and other needed support
• Participate actively in cross-functional teams supporting the Webster Groves commercial plant and projects
• Serve as leading technical expert for key quality or compliance areas
• Create, approve, and implement quality system procedures associated with the product realization process as well as procedures associated with facility management and oversight
• Ensure facility is prepared for FDA and other regulatory body inspections
• Support scorecard development, maintenance, reporting and action / project development from scorecards
• Evaluate and provide risk-based QA decisions on all systems and issues that are/may be affected by regulatory or cGMP requirements - escalate to senior leadership as appropriate

MINIMUM REQUIREMENTS:

Education:

• Minimum BS in Chemistry, Chemical Engineering, related science or equivalent combination of Education, Experience and Competencies
• Advanced degree preferred
• Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
• Certification as a Quality Auditor or Quality Manager helpful

Experience:

• Minimum 5 years' experience in a quality engineer or equivalent role
• Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
• Preferred experience including, but not limited to the following:
  • Solid dose product experience
  • Application of cGMP to manufacturing and testing
  • Product release and investigations
  • Change Management and CAPA
  • FDA inspections / Regulatory Affairs
  • Validation

Skills/Competencies:

• Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
• Critical problem-solving skills
• Demonstrated data driven decision making ability
• Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
• Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)
• An understanding of the pharmaceutical industry and its unique business and social responsibilities
• Excellent facilitation and presentation skills
• Ability to plan, organize, and prioritize
• Excellent technical and compliance-based writing skills
• Ability to work with clients of diverse incumbent skill base
• Ability to manage projects involving multiple functional groups without direct reporting authority

Other Skills/Competencies:

• Strong communication skills
• Demonstrated leadership abilities
• Demonstrated commitment to excellent customer service
• Conflict resolution skills
• Requires mature judgment in problem solving situations.
• Requires negotiation skills to effectively influence others
• Ability to identify and drive continuous quality improvement

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

• Reports to Head of Quality
• Dotted line relationship with Operational Manager
• Works under self-direction toward predetermined long-range goals and objectives
• Assignments and tasks are self-initiated and self-monitored
• Determines and pursues courses of action necessary to obtain desired results
• Requires minimal direction
• Routine interaction with other company manufacturing facilities and corporate functions

WORKING CONDITIONS:

• Office, production and laboratory environment

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.