Head, Corporate Quality – Microbiology
Location: Cranbury, NJ
Job Category: Quality Assurance
Employment Duration: Full time
Responsible for all corporate strategy, overall Microbiology policies and standards, global Microbiology training program aspects of Microbiology across all SUN Pharmaceutical Globally. Provide overall GMP strategic direction for all compliance activities, consistent with Corporate Quality policies, programs and objectives.
Act as a champion for building a “culture of quality” across the organization. Proactively assess compliance issues and risks in Microbiology Lab of all manufacturing Sites of the Company, providing strong leadership and expertise and setting and maintaining compliance standards throughout the Company’s complete value chain.
Essential Job Functions:
Effectively manage the activities and resources necessary to support the organization’s compliance and business needs. Responsible for providing input and direction in support of our Global Microbiology Program. Also accountable for supporting sites for Inspections, response to the Inspection observations, support site for Microbiology / sterility issues as the Global SME.
Support QA regions / Heads with risk assessment for Microbiology at all sites, and set up global Microbiology metrics for all labs as well as assure Microbiology training / certification program at the sites.
Responsible for the efficient use of human resources and the adequate staffing of all areas with capable trained personnel aligned to Operations and departmental objectives. Performance measures are utilized to ensure that departmental activities are effective and timely and as the basis for continuous improvement. Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. Ensure that performance issues are managed in a consistent and timely manner. Develop departmental expense, capital budgets and headcount projections. Track and manage expenditures and headcount to budget over the fiscal year. Act as a key knowledge resource for the interpretation and application of cGMP requirements for all markets in which Sun Pharmaceuticals operates or markets products.
Direct efforts to communicate Company’s Compliance policies, including written materials and training programs designed specifically to promote understanding of compliance issues, laws and regulations, and consequences of non-compliance. Responsible for the development of global strategy to respond to system level audit observations, inspection findings and implement corrections globally. Support all site in creating SME of Microbiology to make plant more independent. Provide support and coordinate major global Microbiology Projects. Create global Microbiology Governance structure. Responsible for microbiology analytical method enhancement, troubleshooting, issuance of global method validation policies and to close method development and validation gaps. Ensure the continuous improvement, rationalization and management of Quality processes and systems. Perform gap analysis to plan actions for continuous improvements.
Provide strategic compliance direction and support to all site Microbiology leaders. Develop and maintain business metrics and reporting tools to monitor and review compliance activities globally. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory, compliance and safety requirements.
Requirements and Qualifications:
A minimum of a Master’s degree in Microbiology or Pharmacy is required. A Doctorate degree in Microbiology would be an asset. A minimum 15 years of experience in a pharmaceutical QA business (or any of its support industries) including 5 plus years in a leadership position managing Compliance programs is required. A strong knowledge of GMP’s in both domestic and international regulatory environments is required. Excellent and detailed knowledge of Microbiological aspects, processes and programs for development and commercial products including regulatory requirements on a global level; working knowledge of safety and environment regulations and guidelines is also required.
A proven ability to lead, manage and motivate people with a variety of skill sets is required. Strong organizational, interpersonal and communication skills are essential. Excellent negotiation and interpersonal skills and ability to communicate effectively with all levels of the organization and external stakeholders and the ability to work effectively in an international multicultural matrix organization is strongly preferred.
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