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Job Profile
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Top Echelon Network
Director of Quality / Small Molecule
Job Location: San francisco, CA
Experience: 5-15 years of experience
We are seeking a top notch Small Molecule Quality Director to work for a leading research and biotechnology firm. Put your expertise to work!
The Director of 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.
Key Job Responsibilities:
Implement and maintain a system to facilitate introduction of new raw materials, including reagents and components used in manufacture of small molecule clinical products.
Implement a system for appropriate sampling and sample retention for clinical products (including chemicals, reagents, components, and processing aids).
Oversee testing of intermediates, bulks, and final products to determine suitability versus pre-established written specifications.
Assure appropriate investigations of Out-of-Specification test results.
Direct and develop Small Molecule Quality Department staff
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 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
Permanent position with an employee centered company offering great benefits, salary and relocation assistance.
The qualified candidate will have:
Minimum of a BS degree, ideal candidate as an advanced degree or Doctorate
Broad working experience to have included technical and QA/QC management positions
10+ years in the biotech or pharmaceutical industry, with at least 5 years of increasing management responsibility, with significant experience in a Quality function
Strong Quality Systems development and management required, ability to develop internal company standards to include QS Administration and SOPs
Technical expertise related to small molecules is required broad laboratory systems background with working current knowledge of international cGMPs, EHS requirements, and regulatory and industry technical standards
Excellent communication, interpersonal, and organizational skills are critical.
Click Here to Apply
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