The Senior Manager of QC Laboratory is a regional
leader for the MC Supply Chain Quality Control laboratories and leads the Asia
(ASPAC) team of Quality control laboratories (as a regional hub lead). The Senior Manager of QC Laboratories reports
directly to the Senior Director QC Laboratory. This position acts as the single
point of contact for laboratory leads and stakeholder interfaces in China and
India regions and is responsible for overall laboratory
operations. In addition, may perform
laboratory lead role in one of the laboratories that are part of the ASPAC
DUTIES & RESPONSIBILITIES
· Successful execution of QC testing and operating strategies for existing product portfolio’s as well as for new products and launch to maximize the efficiency and effectiveness of the QC laboratory operation.
· Establish the implementation of new technologies and processes that take forward strategies to maximize productivity and reduce testing cycle time.
· Partner effectively with R&D and MAKE to embed quality control in our supply chain processes, such as PAT (Process Analytical Technologies) and DTV (Design to Value)
· Partners with local site staff and stakeholders (R&D, Make, Source, BQ, QA, etc) and is accountable for the implementation and maintenance of key performance indicators/ metrics. Ensures that production and quality levels meet or exceed organization and customer expectations.
· Ensures alignment of regional hub with MD QC laboratories Global Laboratory Capability Centers (GLCC) as required. Works with peers and other QC leaders to deploy and embed harmonized processes through the GLCC.
· Develops and deploys cost competitiveness focus and ensures the culture of continuous improvement of business performance is strong
· Working with GLCC, ensures scalable and flexible capacity utilization, utilizing both internal and external laboratory capabilities to address changes in demand
· Manage escalation issues or testing interruptions in conjunction with the local QC lead and site QA
· Ensure strong budgetary CAPEX and OPEX management
· Responsible for communicating business related issues or opportunities to next management level
· Perform lab lead role for the laboratory overseeing QC testing activities
· People management of a globally-dispersed diverse staff and related stakeholders in quality activities to optimize favorable outcomes and ensure balanced decision-making. Fosters organizational development. Creates and drives a high level of commitment to customer service.
· Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
· Develops and manages budget, organizational structure and business requirements / metrics to accommodate business needs
· Performs other duties assigned as needed
EXPERIENCE AND EDUCATION
· University/Bachelors degree required. Preferred field of study includes life sciences.
· 6-8 years relevant experience is required including 5 years laboratory supervision experience is required.
· In-depth understanding of medical devices processes and manufacturing, and GMP requirements is preferred
· Experience in dealing with internal & external stakeholders, both regulatory stakeholders as well as external business partners. Good knowledge of international regulatory requirements and agencies.
· Demonstrated knowledge of GxP regulations and proven cycle of success in implementing and maintaining GMP compliance.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
· Interpersonal partnering capabilities with a focus on customer service and delivering results with the ability to build and nurture strong and positive relationships with Therapeutic Areas, Commercial and R&D leadership. Ability to communicate across all levels of the organization.
· In-depth understanding of medical devices processes and manufacturing, and GMP requirements
· Demonstrated business skills, including financial acumen and business planning with previous experience with budget and capacity planning (OPEX, CAPEX, headcount). Demonstrated experience in delivering business improvements projects.
· Ability to translate strategy to execution for local laboratories to ensure ability to achieve business results.
· Ability to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile and rapidly changing environment
· Knowledge of the business environment inside a quality organization across various roles
· Certification in Lean/Six Sigma an advantage
· Fluent verbal and written English communication skills; other language skills advantageous