Associate Director Quality Control, Val-de-Travers

Vor 2 Tagen

ValdeTravers, Schweiz TN Switzerland Vollzeit

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Associate Director Quality Control, Val-de-TraversClient:

WuXi AppTec

Location:Job Category:

Other

Job Reference:

decfaafc718b

Job Views:

9

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Overview

This position is a key leadership role being responsible for the direct management of individual contributors, supervisors and managers.

This position is a role model for the WuXi values and competencies.

Job Summary:

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.

Accountable for all analytical and microbiological incoming, release & stability testing, and the transfer, verification and validation of new methods related to New Product Introductions.

Accountable for delivering on time and cost-effective quality control through the effective utilization of resources in accordance with all Good Manufacturing Practices (GMP) practices, whilst taking into consideration the company's commitment to our Core Values and Behaviors in the planning and implementation of tasks.

Responsibilities

Department management

  • 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.
  • Ensure department processes are sufficiently defined and documented. KPIs are implemented & 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 resource allocation 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).

Quality Control

  • Accountable for the on-time delivery of all QC activities, to ensure overall on-time delivery to our clients.
  • 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 needs.
  • Identify and coordinate continuous improvement & process optimizations within QC and across the site.

New Product Introduction

  • Accountable for building and maintaining good relationships with clients who have a Quality Control interest.
  • Responsible for organizing activities & documentation of interest for clients or STA visitors on site.
  • Responsible for proposing solutions to client’s requests, especially where there is a conflict with other department activities.
  • Immediate escalation of client concerns to the project manager and site head.

Compliance

  • Accountable for the planning, execution and tracking of all compliance activities (GxP as well as other regulatory requirements).
  • Accountable for the department's related topics during audits & inspections.
  • Process definition, and management of documentation (SOPs, Job Descriptions, etc.), ensuring alignment to corporate policies, regulatory requirements and best practices.
  • Lead complex deviation investigations, change management, and critical quality complaint resolution activities.

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.
  • Ensure that staff are properly informed on hazards, and trained to act accordingly.
  • Promote safe practices and verify that EHS rules are implemented and respected.

Qualifications

Experience / Education

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

Knowledge / Skills / Abilities:

  • Known for exceptional management of teams to maintain an environment of personal accountability and trust.
  • Decisive leader; able to take important decisions under pressure and drive successful execution.
  • Strong working knowledge of GMP and FDA, Eudralex, PICS and GAMP regulatory requirements.
  • 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.

Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.

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