Consent Decree Champion Manager (closed)
Contract position-24-30 months
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Consent Decree (CD) Champion will direct and guide a group of local QSE Leads on the execution of Consent Decree-related commitments.
• CD Champion will liaise with Lancaster CD Site Lead / CDMO, Home Office CDMO personnel and site base business to ensure all identified gaps and interdependencies between QSEs and Base Business are well understood and addressed
• Lessons learned are shared between all QSE Teams at the site and CDMO
• Ensure risks are identified, communicated and tracked to resolution.
• Assist with Metric design, data collection and tracking for assigned QSE Teams
• Appropriate incorporation of Points for Further Evaluation from other QSE’s
• Ensure all supporting documentation is identified and tracked by the team members to closure (Open Investigations, Change Controls), prior to confirmation of a step
• Coach and mentor assigned QSE Teams in cGMP, industry trends and coorporate guidances
• Assist in data gathering to support scheduling of base Business resources that will be required for success of QSE Step execution.
• Ensure a strong sustainability model is put in place, tracked and communicated to site CDMO
Bachelor’s degree in a Science, Engineering or related discipline.
8 years experience in the OTC, Medical Devices or Pharma regulated environment. Breadth and depth in multiple quality systems principles and practical application, such as Change Controls, Validations, Investigations, CAPAs, Complaints, manufacturing operations, Facilities and Batch Record Review. In depth knowledge and experience in various senior Technical and/or Quality Assurance roles.
Breadth of knowledge and experience applying cGMPs, with an ability to interpret those in a fast-paced environment. Senior management experience. Project Management experience is a plus.
Strong problem solving skills. Excellent oral and written communication skills. Process Excellence or Six Sigma certification. Strong presentation skills. Proven leadership with significant experience in demonstrating effective influence of senior management (Senior Directors and above). Demonstrated ability to be assertive. Demonstrated sense of urgency. Demonstrated application of quality and risk management principles and tools. Strong interpersonal skills, with demonstrated ability to influence stakeholders. Demonstrated ability to work and collaborate in cross-functional teams. Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands. Capable of working independently. Microsoft Projects is a plus.