Associate Director Quality Control Lead
vor 4 Wochen
This is a key leadership role responsible for the direct management of individual contributors, supervisors, and managers within the Quality Control department at WuXi AppTec.
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 we are working on the right things.
- Manage teams by setting and tracking goals and tasks, continuously improving processes to ensure we are doing it right.
- Ensure proactive priority and daily activity management for teams and activities.
- Ensure department processes are sufficiently defined and documented, with KPIs implemented and monitored.
- Communicate proactively, consistently, and collaboratively with peers, stakeholders, and partners.
- Use risk management and scientific assessments to ensure resource allocation is commensurate to 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).
- 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).
- 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, and capacities to better meet client needs, mitigate compliance risks, etc.
- Identify and coordinate continuous improvement and process optimizations within QC and across the site.
- Accountable 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, responsible for their well-being.
- Organize in advance the activities and documentation of interest.
- Meet at reception, or delegation.
- Accompany throughout the site.
- Accompany during lunch.
- Ensure relevant activities can be seen, and provide documentation.
- Return to reception, or delegation.
- Responsible for proposing solutions to client requests, especially where there is a conflict with other department activities.
- Immediate escalation of client concerns to the project manager and site head.
- 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 and 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.
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.
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 a scientific field or equivalent.
Known for 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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