The Director, Small Molecule Clinical Quality will oversee a group responsible for the building, maintenance, and improvement of compliant and robust Clinical GMP Systems that are sufficiently flexible to support development and operational needs for small molecules. Collaboratively set the vision, direction, implementation, and on-going enhancement of clinical GMP systems and business processes. The Director manages QC operational activities for small molecule clinical products produced in SSF or externally. The position oversees development, validation, and implementation of test methods and control systems for small molecules. This position is also responsible for standards and standard operating procedures used in testing and evaluating products and raw materials, in order to deliver a high quality, cost effective service, covering all customer (internal and external) analytical and process development requirements. Achieve clarity with respect to expectations of consistency of quality systems and standards relative to External Quality and CMOs within a context of recognition and respect for needs for operational flexibility. Partner with local leaders to target and achieve the appropriate understanding and balance. Direct the process for development and delivery of training in required policies, standards and guidance documents. Collaborate with other Quality groups on development of global documents to meet expanding business needs. Identify system and process owners, conduct periodic reassessments, evaluation of change requests, and interpretation of regulatory language and applicability of requirements. Partner with site and business unit local system owners to identify compliance, productivity, and efficiency issues with these systems and to resolve them in the best interests of Genentech.

The position is accountable for ensuring that Quality policies and practices are executed in support of operational goals. The position is accountable for managing the department budget.

Key Job Responsibilities:

Implement and manage all required quality systems for early phase small molecule production, leveraging existing biological product or corporate systems where appropriate.
Oversee production of early phase API, including documentation and lot release.
Oversee testing of intermediates, bulks, and final products to determine suitability versus pre-established written specifications, for both internally and external produced product.
Implement and maintain a system to facilitate introduction of new raw materials, including reagents and components used in manufacture of small molecule clinical products.
Assure appropriate investigation of significant manufacturing events and Out-of-Specification test results.
Direct and develop Small Molecule Quality Department staff
Assure appropriate equipment qualification and maintenance in production and QC
Provide general systems support for GMP activities, including LIMS, DMS, Change Control, etc.
Provide vision and coordinate continuous improvement within the group to optimize systems and processes
Provide technical expertise regarding business processes, testing, and sampling requirements
Provide review of Quality procedures in collaboration with other functional groups
Provide resources and leadership for method validation activities
Provide analytical support to R & D (small molecules), Process and Analytical Development, and Manufacturing, as well as to CMOs.

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