Director - Quality Assurance - Roche - Marlborough

Job description
Responsibilities:
Strong interface with local Operations, Engineering 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.

Determines and implements 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.
Oversees and leads Quality Assurance staff in: Daily support activities to manufacturing; Material controls and disposition; Validation protocol and report review and approvals; Nonconformance, Validation Deviation and Planned Variance handling; and Shop floor and Internal auditing.
Ensures activities including Nonconformance review and approval, Validation protocol and report review and approval, documentation change workflows, Planned Variance review and
Participates in cross-functional meetings/initiatives and sets and maintains the standards for interdepartmental actions and the integration of quality planning with production and operations planning.
Assures local organizations are trained on RMS policies and procedures, and QSR and ISO requirements through the development and implementation of compliance education and training courses.
Responsible for effective performance management, goals and objective setting and personal development planning. Assures short and longer term individual and organizational development needs are identified, planned, and effectively implemented.

Desired Skills and Experience
Qualifications:

Bachelor’s degree in Clinical/Biological Science or related field, or equivalent combination of education and work experience, required.
Master’s degree in Biological Science, Quality Engineering or related field, preferred.
8+ years of quality related experience and 5+ years of demonstrated progressive people leadership, required.
8+ years in the IVD, device or pharmaceutical industry dealing with quality management. Experience with QSR/ISO audit process and conducting audits. Certified Quality Auditor (CQA); Certified Quality Manager (CQM), Federal cGMP’s
Superior communication and interpersonal skills; supervisory skills.

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