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ASSOCIATE DIRECTOR
OF
BIOLOGICAL COMPLIANCE

VA04-NY-0402-18

stephanie.quinones@bms.com

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Position

Based in North Eastern USA



Associate Director
of
Biological Compliance

to lead and manage the QA Operations and QA systems groups

Primary responsibilities of the Associate Director are to lead and manage the QA Operations and QA systems groups and actively support the ongoing Pre-Approval Inspection readiness of the Syracuse Technical Operation site for a new biological compound in late stage clinical trials.

Included in these responsibilities are

  • The development and enhancement of quality systems to promote, facilitate and assure compliance with all regulatory and BMS standards.
  • Providing disposition on bulk biological and finished product, review and approval of deviations, failure investigations, change control, CAPA etc.
  • Management and preparation of Annual Product Reviews, quality documentation management, internal audit programs, and supporting supplier quality audits.
  • In addition, the position requires the hiring, coaching, and development of staff, management of aggressive timelines, and budget responsibilities.

Job Requirements

  • Minimum M.S., preferably Ph.D. in Biological Science or related field.
  • At least 10 years experience in biopharmaceutical quality with 5 to 7 years of increasing management responsibility.
  • Experience in building and growing an organization is desirable.
  • Strong background and demonstrated effectiveness in quality assurance and compliance of commercial biologics in an FDA regulated environment.
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
  • Must be very familiar with US and EU cGMP regulations and guidance.
  • Extensive and proven experience in FDA Pre-Approval Inspection preparation and management is essential.
  • Position requires demonstrated leadership skills and candidate must possess outstanding interpersonal, communication and motivation skills.

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We offer a competitive salary & an attractive benefits package commensurate with experience.

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Visit our website at http://www.bms.com .

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Please mail, fax or e-mail your resume & salary history to

Bristol-Myers Squibb
Stephanie Quinones
1 Squibb Drive
New Brunswick
NJ 08903
USA
Phone: 732-227-6585
Fax: 732-227-3874



e-mail:
stephanie.quinones@bms.com

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