Role Summary
The Senior Director - QC Labs IPM is responsible for the oversight and execution of product testing, including chemical and/or micro tests for raw materials, in-process samples, semi-finished and finished products, as well as physical and functional testing of Drug/Device combination products and visual/physical testing of packaging components. They ensure an adequate quality system is in place for material and product testing, with qualified testing equipment and trained personnel. As a member of site management, they oversee resourcing of the quality control unit and the ongoing development of the quality control team. The role requires multitasking, strong communication, decision making, and the ability to proactively identify and solve problems, while ensuring compliance with cGMP and supporting the business plan. Responsibilities
Maintain a safe work environment, lead safety initiatives, and support all HSE corporate and site goals. Participate in human resource development, planning, and performance management for direct reports; participate on the plant lead team and Parenteral Quality Lead Team. Act as a conduit for corporate communications and demonstrate critical business decision making for successful results. Create and manage the Site Quality Plan; recruit talent, ensure technical and compliance consistency across plants; coordinate and manage regulatory inspections. Communicate with and integrate support groups outside of the plant. Recruit and retain diverse staff, supervise and coach, develop, manage performance, and maintain a fair and equitable work environment. Provide leadership in implementing quality systems and drive improvements in quality processes. Provide technical support for site and corporate on analytical topics; maintain inspection readiness and interact with regulatory agencies during inspections. Network internally and externally to share best practices, support strategic planning, and meet customer needs; collaborate with other sites on new systems and analytical process improvements. Develop plans for capital purchases. Qualifications
Required:
Bachelors of Science degree in Chemistry, Microbiology, or related science field. Required:
10+ years of experience in the pharmaceutical industry with prior supervisory experience. Education
Bachelors of Science degree in Chemistry, Microbiology, or related science field Additional Requirements
Some OUS and US travel may be required. Tasks may require repetitive motion (e.g., keyboarding). Ability to work 8-hour days, Monday through Friday, with overtime as required; available off shift to respond to operational issues. Required to carry company-provided mobile phone and respond to operational issues.
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The Senior Director - QC Labs IPM is responsible for the oversight and execution of product testing, including chemical and/or micro tests for raw materials, in-process samples, semi-finished and finished products, as well as physical and functional testing of Drug/Device combination products and visual/physical testing of packaging components. They ensure an adequate quality system is in place for material and product testing, with qualified testing equipment and trained personnel. As a member of site management, they oversee resourcing of the quality control unit and the ongoing development of the quality control team. The role requires multitasking, strong communication, decision making, and the ability to proactively identify and solve problems, while ensuring compliance with cGMP and supporting the business plan. Responsibilities
Maintain a safe work environment, lead safety initiatives, and support all HSE corporate and site goals. Participate in human resource development, planning, and performance management for direct reports; participate on the plant lead team and Parenteral Quality Lead Team. Act as a conduit for corporate communications and demonstrate critical business decision making for successful results. Create and manage the Site Quality Plan; recruit talent, ensure technical and compliance consistency across plants; coordinate and manage regulatory inspections. Communicate with and integrate support groups outside of the plant. Recruit and retain diverse staff, supervise and coach, develop, manage performance, and maintain a fair and equitable work environment. Provide leadership in implementing quality systems and drive improvements in quality processes. Provide technical support for site and corporate on analytical topics; maintain inspection readiness and interact with regulatory agencies during inspections. Network internally and externally to share best practices, support strategic planning, and meet customer needs; collaborate with other sites on new systems and analytical process improvements. Develop plans for capital purchases. Qualifications
Required:
Bachelors of Science degree in Chemistry, Microbiology, or related science field. Required:
10+ years of experience in the pharmaceutical industry with prior supervisory experience. Education
Bachelors of Science degree in Chemistry, Microbiology, or related science field Additional Requirements
Some OUS and US travel may be required. Tasks may require repetitive motion (e.g., keyboarding). Ability to work 8-hour days, Monday through Friday, with overtime as required; available off shift to respond to operational issues. Required to carry company-provided mobile phone and respond to operational issues.
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