Quality Control Leadership Director

Vor 5 Tagen

ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Job Description

This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers. The Associate Director Quality Control is charged with Overseeing the Quality Control department, providing leadership to the respective teams and ensuring that the highest standards of health and safety are adhered to.

Responsibilities
  • Guide, mentor & develop your teams to achieve an environment of personal accountability and trust.
  • Align with the site to set the strategy & priorities for your teams, ensuring we are working on the right things.
  • Manage your teams by setting & tracking goals and tasks. Continuously improve processes to ensure we are doing it right.
  • Ensure pro-active priority and daily activity management for team & activities (planning communication, team organization, control, checking of the defined targets).
  • Ensure department processes are sufficiently defined and documented. KPIs are implement & monitored, actions are prioritized to ensure KPIs are on target.
  • Communicate pro-actively, consistently, and collaboratively with peers, stakeholders, and partners.
  • Use risk management & scientific assessments to ensure the depth and breadth of resource allocation (people, duration, documentation, etc.) is commensurate to the risk, impact, and the 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).
  • Accountably for the on time delivery of all QC activities, to ensure overall on time delivery to our clients:
  • Raw material, release & 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).
  • Accountability for the timely and compliant execution of delegated activities remains with the department head.
  • Review key department documentation, including procedures, reports, deviations, CAPAs, Change controls, etc.
  • Ensure that out of specifications and deviations are appropriately investigated and resolved;
  • Identify and present business cases to continuously improve, increase capabilities & capacities, to better meet client's, mitigate compliance risks, etc.
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:
  • Known for exceptional management of teams: to maintain an environment of personal accountable 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 organizations.
  • 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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