Danaher Corporation Senior Director, Quality Systems in Lodi,
The Senior Director, Quality Systems will provide management and overall strategic direction and operational coordination of activities for site Quality Operations and Regulatory Compliance. The Senior Director, Quality Systems will serve as the management representative for Cepheid – Lodi and ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements and alignment with company objectives and Quality Standards. The Senior Director, Quality Systems will report directly to the Vice President, Manufacturing Quality and will supervise the Lodi, CA Quality organization encompassing the Quality Control, Quality Engineering, Quality Assurance and Quality Systems functions.
ESSENTIAL JOB RESPONSIBILITIES:
Build, develop and manage a high performing Quality team including Quality Control, Quality Engineering, Quality Assurance and Quality Systems.
Provide validation program leadership for Cepheid facilities, manufacturing processes and equipment.
Maintain the Calibration Program
Maintain the CAPA and NCR systems
Maintain Document Control
Lead site Change Management and Risk Management activities
Directs and oversees the quality planning processes; participates in strategic and tactical planning processes.
Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
Communicates and reports regularly to Quality management, users and staff on the status of the quality system.
Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
Assure that there are no significant interruptions to the business due to quality or compliance issues
Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systems.
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Education and Experience (in years):
Bachelor's Degree in Engineering, Biology, Biochemistry, or related field with 14 years of related experience OR
Master’s degree in field with 12+ years of related work experience
4 years of Supervisory or Department Lead experience in managing both processes and resources
Knowledge and skills:
Medical Device industry experience, preferably IVD
Expert knowledge of US FDA and ISO requirements
Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
Extremely detail-oriented with strong organizational skills and high Quality standards
Develop strategic goals and objectives from knowledge base and understanding of a customer’s business.
Manage changing conditions, processes and approaches; lead organizations through change effectively.
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.
Track record of measurable, operational improvements to Quality Systems related functions.
DBS, LEAN or Six Sigma operational excellence training or certification
Seven years of Department Leadership experience in managing both processes and resources.
Training and certificates in quality or regulatory affairs (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
Experience in Manufacturing Operations
Experience with molecular diagnostics
Experience managing both Direct and Indirect labor.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .
Operating Company: Cepheid