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Associate Director, Compliance and Quality Systems

Employer
Bristol Myers Squibb Company
Location
Devens, MA, United States
Start date
Feb 25, 2019

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Job Details

Responsibilities:

Compliance
  • Facilitates all health authority inspections and BMS internal audits, including planning, execution and follow-up. Includes on-site inspections as well as remote (aka desktop) audits.
  • Maintaining inspection readiness program for site personnel, including any periodic training and practice opportunities.
  • Includes facilitation of BMS Global Regulatory Observation (GROe) program and BMS Policy/Directive review for site impact.
  • Prepare required health authority documentation as part of maintaining active GMP certification as well as support of new applications to new markets.
  • Oversee the site self-inspection (internal audit) function to ensure that the site meets current health authority and BMS corporate requirements.
  • Manages and provided Quality Review of Annual Product Quality Review Report elements as established in products / systems schedule.


Quality Systems
  • Facilitates the Devens Site Quality Council by developing and monitoring the scorecard of key metrics, as well as the Site Quality Plan of key continuous improvement and emerging topics.
  • Oversee the Quality Risk Management program including owning the site risk register.
  • Oversee the Change Control program to ensure that change requests are properly assessed for impact.
  • Oversee the Supplier Quality program to ensure that suppliers and materials are fit for use in GMP manufacturing, which includes material and supplier qualification, as well as oversight of life cycle activities such as supplier audits/agreements, complaints/investigations and change notification.
  • Oversee the Training program to ensure that site colleagues have the training courses needed to perform GMP activities.
  • Oversee the Records Management program to ensure that documentation is available for use according to mutually defined service level agreement.
  • Includes ensuring that our Documents and Records Management strategy meets all health authority requirements for Data Integrity.


People Leadership
  • Hires and develops qualified managers and staff.
  • Ensures that staff have adequate training, education and experience to perform their GMP related job function effectively.
  • Oversee budget adherence to department cost center.


Requirements:
  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent.
  • A minimum of 7 years experience in biopharmaceutical quality or its equivalent with an additional 6 to 10 years of increasing management responsibility.
  • Experience in building and growing an organization is desirable.
  • Expertise in ICHQ9 and Quality Risk Management Program Implementation is required.
  • Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics in a FDA and EMA regulated environment.
  • Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
  • Extensive knowledge of US and EMA GMP regulations and guidance.
  • Proven experience in Inspection preparation and management is required.
  • Demonstrated leadership, interpersonal, communication, and motivation skills.
  • Knowledge of computerized systems such as SAP, LIMS, Maximo, Trackwise, Syncade and DeltaV are desirable

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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