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Associate Director Quality Control

vor 4 Monaten

Couvet, Schweiz WuXi AppTec Vollzeit

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, this position provides leadership to the respective teams and ensures 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.


Department management

  • Guide, mentor & develop your teams to achieve an environment of personal accountability and trust.
  • Do the right thing (be effective): align with the site to set the strategy & priorities for your teams, ensuring we are working on the right things,
  • Doing it right: (be efficient): 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).

 

Quality Control

  • 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.
    • g. the responsibility (execution) of raw material sampling has been delegated to the Warehouse team.
  • 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.
  • Identify and coordinate continuous improvement & process optimizations within QC and across the site.

  

New Product Introduction

  • Accountably for building and maintaining good relationships with clients who have a Quality Control interest.
  • When clients or STA visitors are on site specifically with a Quality Control interest (e.g. form the client or STA QC department), responsible for their wellbeing. Including:
    • Organizing in advance the activities & documentation of interest,
    • Meeting at reception, (or delegation)
    • Accompanying throughout the site,
    • Accompanying during lunch,
    • Ensuring relevant activities can be seen, and providing documentation,
    • Returning to reception, (or delegation)
  • 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). Including:
    • Accountable for the departments related topics during audits & inspections (including regulatory, compliance, client and corporate)
    • Process definition, and management of documentation (SOPs, Job Descriptions, etc.), ensuring alignment to corporate policies, regulatory requirements and best practices.
    • Training Curriculum definition and on-time completion of training,
    • Follow up, coordination and management of CAPAs, deviations and Change Controls.
    • Lead complex deviation investigations, change management, and critical quality complaint resolution activities.

 EHS:

Line Managers shall provide a safe and healthy work environment for their staff in areas under their control and shall ensure compliance with relevant rules and legislation in those areas.

    • Identify 1 (or more) 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 (including short duration and temporary contracts) are properly informed on hazards, and trained to act in consequence,
    • Promote safe practices and behaviors, verify that EHS rules are implemented and respected.

 


 

Experience / Education  

 

  •  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