Senior Quality Control Director

Vor 2 Tagen

ValdeTravers District, Schweiz WuXi AppTec Vollzeit

Job Summary:

The Senior Quality Control Director will oversee the Quality Control department, providing leadership to the respective teams and ensuring adherence to the highest standards of health and safety. This role is responsible for delivering on-time and cost-effective quality control through the effective utilization of resources in accordance with Good Manufacturing Practices (GMP) practices.

Key Responsibilities:

  • Guide, mentor, and develop teams to achieve an environment of personal accountability and trust.
  • Align with the site to set strategy and priorities for teams, ensuring the right things are being worked on.
  • Manage teams by setting and tracking goals and tasks, continuously improving processes to ensure efficiency.
  • Ensure proactive priority and daily activity management for teams and activities.
  • Communicate proactively, consistently, and collaboratively with peers, stakeholders, and partners.
  • Use risk management and scientific assessments to ensure resource allocation is commensurate with risk, impact, and ROI.
  • Keep up to date with current industry best practices that may give an operational or strategic advantage to WuXi.
  • Accountable for the department budget (OPEX and CAPEX).

Quality Control:

  • Accountable for the on-time delivery of all QC activities to ensure overall on-time delivery to clients.
  • Raw material, release, and stability testing.
  • Transfer, verification, and validation of new methods.
  • LIMS and support functions.
  • Accountable for the delegation of activities within the site, within STA (to other sites), or outside of STA (external suppliers).

New Product Introduction:

  • Accountable for building and maintaining good relationships with clients who have a Quality Control interest.
  • Responsible for the wellbeing of clients or STA visitors on site specifically with a Quality Control interest.

Compliance:

  • Accountable for the planning, execution, and tracking of all compliance activities (GxP as well as other regulatory requirements).
  • Accountable for the departments related topics during audits and inspections.
  • Process definition and management of documentation (SOPs, Job Descriptions, etc.).
  • Training Curriculum definition and on-time completion of training.
  • Follow-up, coordination, and management of CAPAs, deviations, and Change Controls.

EHS:

  • Identify members of your department to be part of the site EHS team.
  • Work closely with EHS to evaluate hazards and perform risk analysis.
  • Promote safe practices and behaviors, verify that EHS rules are implemented and respected.

Qualifications:

  • 15+ years experience in a pharmaceutical company or other related GMP industry, ideally in solid dosage forms.
  • 10+ years people management experience, preferably Quality Control.
  • University Degree in scientific field or equivalent.

Knowledge/Skills/Abilities:

  • Exceptional management of teams to maintain an environment of personal accountability and trust.
  • Decisive leader, at ease to take autonomously important decisions under pressure and to drive successful execution.
  • Organized and rigorous.
  • Strong working knowledge of GMP and FDA, Eudralex, PICS, and GAMP regulatory requirements.
  • Excellent change management and organizational skills.
  • Demonstrated ability to effectively communicate (verbal and written) within their team and at all levels of the organization.
  • Proven track record of attaining targets while upholding the highest standards of health and safety.
  • Exceptional problem-solving ability, advantageous lean/Six Sigma.
  • Experienced at presenting during regulatory audits (FDA and SwissMedic).
  • Fluent in French and English.

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