Associate Director - Quality

Location
Bern, Canton of Bern (CH)
Salary
Competitive salary + benefits
Posted
09 Jun 2021
Closes
09 Jul 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Responsibilities

  • Assures adequate release of product that meets requirements per product specifications to applicable geographies.
  • Collaborate with Production and Manufacturing Sciences management in the areas of cGMP compliance and quality systems.
  • Provides direction in the event of manufacturing incidents that may potentially affect quality or compliance.
  • Responsible for management of investigations, CAPAs, batch record review, product release, change control, requalification and product annual review.
  • Responsible for review and approval of changes to process, equipment, procedures, and systems.
  • Support the facility during external and regulatory inspections.
  • Implement lean concepts to continuously improve cycle times within the area or responsibility
  • Participate to core team meetings and support division-led improvement projects
  • Act as QP delegate and lead the weekly QP meetings

Qualifications

  • Must have 8-10 years’ experience
  • 5 years experience in leadership, supervisory or management experience in the pharmaceutical or biotechnology within Quality
  • University degree or equivalent in Engineering, Chemistry, Life Science or other job related discipline.
  • Certification desired in ASQ, Green Belt, Lean or equivalent
  • Strong knowledge of cGMP (US, Swiss, EU, Canadian, Japan) required
  • Demonstrates proficiency in multiple quality systems including exception management, change control, document control, product release, supplier quality, etc. with strong decision-making skills utilizing risk management.
  • Lead multiple tasks/projects within timeline: strong verbal, written, oral communication skills. Able to present business indicators to senior management.
  • Fluent in English and in French.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

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