Quality Operations Director Job in Durham, North Carolina US
Quality Operations Director
Merck is a global health care leader with a diversified portfolio of prescription medicines, vaccines and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Accountable for Quality Assurance (QA) operations of Active Pharmaceutical Ingredients including materials and product disposition, investigations, CAPAs, shop floor and in-process QA activities, product complaints, qualification and validation and audits. Leads and facilitates the integration of the quality operating systems, management infrastructure and colleagues mindset and behaviors to achieve financial goals ensuring compliance of processes with regulatory requirements while promoting an environment that encourages creativity, innovative ideas, and engagement as well as a high performance culture. In partnership with the QO Technical Lean Operations Leader, incumbent will lead and facilitate the integration of all Quality Operations, compliance systems, management infrastructure and colleagues mindset and behaviors. This will help leading the Durham site to achieve its financial goals ensuring compliance with all regulatory requirements while promoting an environment that encourages creativity, innovative ideas, and engagement as well as a high performance culture within the site and the immediate site network within Durham. ESSENTIAL FUNCTIONS: The essential functions of this position include, but are not limited to: Controls the manufacturing steps of Active Pharmaceutical Ingredients to assure adherence to cGMPs, corporate, plant policies and procedures, and regulatory requirements. Coordinates the activities and directs the efforts of QA personnel to meet quality standards. Primarily responsible for the timely release of products within plant and regulatory requirements. Establishes, improves and maintains quality programs, procedures and controls for the assigned areas. Assures full compliance of the following Quality systems: Change Management, Validation, Deviations, Commissioning and Qualification. Monitors and advises on the performance of the quality management system by producing data and reporting through measurement against set department indicators. Reviews product and/or process failures to evaluate and determine if added tests or manufacturing changes are required to prevent recurrence. Responsible for determining appropriate skilled staffing for tasks execution. Effectively delegates and assigns tasks according to the levels of support and direction needed. Allocate resources as needed to meet business demand and support the on time completion of area deliverables. Creates work plans and assigns tasks without leadership intervention. Assess the need for contracted or temporary resources. Provides leadership and guidance to drive balance between compliance and business needs in the resolution of quality and technical issues. Guides subordinates to resolve issues. Meets established priorities to maintain product supply. Liaises with other Leaders and staff throughout the organization to ensure that the QA system is functioning properly. Partners with other departments towards the resolution of technical issues. Supervises inspection, product disposition and QA technical support personnel to achieve established goals and standards. Trains and develops inspection, product disposition and QA technical support personnel to assure understanding and compliance with GMPs and other regulatory requirements. Assist in preparing, analyzing and controlling the Quality Assurance operating budget plan. Manages compliance with EEO safety guidelines established by plant management. Identifies and implements cost improvement projects. Supports the development of departmental objectives aligned with Company/Site/Department objectives. Responsible for assuring that colleagues are properly trained to execute their duties. Accountable for providing timely and appropriate counseling and feedback to employees as necessary to achieve department and site objectives. Develops a plan for short and long range development of colleagues under his/her responsibility. Responsible for performance assessments and salary recommendations. Promotes an environment conducive to creative/innovative ideas to improve areas performance. Promotes respectful and constructive relationships with direct reports and co-workers Versatile and willing to be assigned to different areas. Balances authority and influence to make things happen. Takes time to understand issues and address root causes. Analyzes, and makes adequate and quick decisions. Acts and leads in alignment with goals, improving collaboration and team work. Understands and accepts the impact of decisions without blaming others. Capable to provide and receive coaching. Manages conflicts effectively and is open to receive feedback. Deploys information and keeps direct reports communicated about plant strategies, vision and direction. Aligns colleagues and departmental actions and goals with Vision. Understands and enforce company policies. Creates an environment in which direct reports are open to provide feedback and ideas. Communicates effectively progress of department towards achievement of goals and indicators. Identifies vulnerable areas and creates/proposes plan to make sure situations are resolved.