Director - Quality Assurance - Roche - Branchburg

Job description

Strong interface with local and global Operations, Quality Management, Regulatory and Development to assure all products and processes are in accordance with company standards and quality systems. This is accomplished through Strategic Quality Planning, Quality System execution and maintenance, non-conformance, corrective and preventive action reporting and follow-up, quality audits, performance metrics and continuous improvement projects.
Ensures the Roche Diagnostics Quality Policy is understood, implemented and maintained in the organization.
Establishes and maintains an adequate organizational structure, provides adequate resources, and establishes appropriate management controls to ensure their group is suitable and effective to satisfy regulatory requirements and the company’s quality policy and objectives.
Determines and implements the best strategic direction for Quality Assurance with regard to organization, competencies, human and fiscal resource planning, quality planning and Quality assurance best practices. Coordinates Quality Assurance activities in support of Manufacturing Operations and associated Development activities.
Develops and drives a work culture committed to compliance, quality and customer focus. Reports to the Head of RMD Quality. Has full budget responsibility for assigned functional area or department.
Decisions affect success of own area(s) and organization-wide success. Sets and maintains the standards for interdepartmental actions and the integration of quality planning with Manufacturing Operations. Provide Quality and Compliance guidance as needed to all parts of the business. Leads project teams where required.
Provide strategic direction, decision making, leadership and planning including the efficient and effective use of resources. Achieves results through the leadership of managerial, professional and/or support staff.

Desired Skills and Experience
Education:
Bachelor’s degree in Biological Sciences or related field. Master’s Degree (preferred)
Job-related Experience:
At least 8+ years’ experience in quality related area.
At least 5+ years of demonstrated experience in leadership positions with demonstrated effectiveness in recruiting, motivating, managing and developing personnel, experience in change management.
8+ years (or equivalent) experience in Quality Concepts; Knowledge and experience in IVD, Pharmaceutical, and /or Medical Device industry; Quality Engineering, Quality Auditor and/or Quality Manager knowledge; cGMP’s and QSR’s, ISO13485.
Other Qualifications:
Must have solid experience with handling FDA inspections.
Must have superior interpersonal, communicative, and leadership skills, above average communication and presentation skills as well as the ability to effectively communicate with various target groups.
Must have experience in analysis of QA process, especially analysis of efficacy and efficiency, combined with a high level of motivation and initiative to challenge the “status quo”.
Must have an independent working style and organizational competency.
Preferred: SAP, Trackwise, MS Project, Visio, Statistical Analysis Software.
Preferred: ASQ Certified Quality Manager (CQM), Engineer (CQE), Auditor (CQA).
Fluency in English required.
Up to 15% travel required.

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