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Associate Director Quality Control, Val-de-Travers Client: WuXi AppTec
Location: Job Category: Other
Job Reference: decfaafc718b
Job Views: 5
Posted: 18.03.2025
Expiry Date: 02.05.2025
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. 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.
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.
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 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.
Accountable for the delegation of activities within the site, within STA, or outside of STA.
Ensure that out of specifications and deviations are appropriately investigated and resolved.
Identify and present business cases to continuously improve, increase capabilities & capacities.
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 their wellbeing when clients or STA visitors are 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.
Accountable for the departments related topics during audits & inspections.
Process definition, and management of documentation.
Training Curriculum definition and on-time completion of training.
Lead complex deviation investigations 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.
Promote safe practices and behaviors, verify that EHS rules are implemented and respected.
Qualifications
Experience / Education
15+ years experience in a pharmaceutical company or other related GMP industry.
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.
Decisive leader; able to take important decisions under pressure.
Strong working knowledge of GMP and FDA regulatory requirements.
Excellent change management and organizational skills.
Demonstrated ability to effectively communicate 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.
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