Quality Recruiting. Established Experts.

Associate Director of Strategic Sourcing

Reference Number: 3048
Location: CA

Our client is a major global healthcare company.  They have asked us to assist them in their search for an Associate Director of Strategic Sourcing.

Major tasks and responsibilities will include:

  • Oversees raw material inspection and sampling strategies in alignment with local QC raw material testing group.
  • Ensures compliant processes for sample management across the QC laboratories are in place. Ensures processes are revised as needed in light of future QCAC and QCMV expansions as well as new systems implementations.
  • Ensures compliant testing of raw materials in accordance with current compendial (USP, EP, JP) and cGMP requirements. Oversees the authoring, reviews and revisions of technical registration documents related to raw materials and submissions to regulatory agencies.
  • Partners and aligns with laboratory managers on content on submissions. Partners with
  • Global Regulatory Affairs and Global QA Change Control to address responses to regulatory requests and comments.
  • Oversees and provides leadership to define and/or maintain user requirement specifications for raw materials used in the production of licensed products.
  • Establishes and implements strategies related to continuous process verification and statistical process control of raw materials in collaboration with Global and Local Quality.
  • Ensures conformance to all regulatory requirements, including those of the FDA and various international regulatory governmental bodies. Interprets those regulatory agency requirements to staff, and guide those personnel as they respond to changing regulatory requirements. Interacts directly with auditors/inspectors from FDA, EMA and other governmental regulatory agencies, as well as partners/suppliers.
  • Represents the function at operational and cross-functional meetings, including discrepancy investigations, and providing technical expertise and disseminating information back to their functional groups. Interacts with departments related to product/process design, product/process transfer, product manufacture, release and distribution as needed. Partners on various projects with stakeholders on site and globally.
  • Provides effective leadership including: selecting key personnel and motivating members of the functional area; assisting with Performance Calibration/Talent Pool Management; individual goal setting/performance reviews; managing the development of employees, training and development; supporting managers in team activities and Transition Workshops; supporting workforce diversity, quality and safety and supporting supervisors/managers in individual/department/business objectives. Works on complex problems in which analysis of situations or data requires in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Ensure schedules and performance requirements are met. Erroneous decisions will result in critical delay(s) in schedules and/or unit operations and may jeopardize overall business activities.

We seek candidates with the following qualifications:

  • Ph.D. in Life Sciences, Chemistry, or related field.
  • 10 years of experience in pharmaceuticals and/or biotechnology industry with 7 years in management positions or an equivalent combination of education and experience.
  • Sound knowledge of cGMP and regulatory compliance (US and other international agencies).
  • Practical knowledge and sound understanding of pharmaceutical, biologics, drug development process from development to product launch and support of commercial products.
  • Expertise in analytical methods development and validation.
  • Knowledge of raw material requirements in the biopharmaceutical industry.
  • Strong knowledge of statistics and statistical tools - thorough understanding of statistical systems.
  • Ability to multi-task and adapt to changing business requirements in a dynamic corporate environment.
  • Effective problem solving.
  • Systematic and quick decision making.
  • Strong leadership, interpersonal, communication and team building skills.
  • Integrity and commitment to company.

 

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3048. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.