Associate Director Quality Control

vor 4 Monaten

Couvet, Schweiz Wapt Vollzeit

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 Contro**l 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.
- 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 e

  • Associate Director Quality Control

    vor 4 Monaten

    Couvet, Schweiz STA Pharmaceutical Vollzeit

    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 Contro**l is charged with Overseeing the Quality Control department, this position...

  • Senior Quality Control Analyst

    Vor 2 Tagen

    Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    Job Title: Senior Quality Control AnalystWe are seeking a highly skilled Senior Quality Control Analyst to join our team at WuXi AppTec. As a Senior Quality Control Analyst, you will play a critical role in ensuring the quality of our products and services.Key Responsibilities:Perform analytical testing according to raw material and product release...

  • Senior Quality Control Analyst

    Vor 6 Tagen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    OverviewAs a Sr QC Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company's quality assurance and quality control program.QualificationsExperience / EducationYou should have a BS/BA in Life Sciences or related field. Minimum of 7 years'...

  • Senior Quality Control Analyst

    Vor 2 Tagen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    As a Senior Quality Control Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program.   (This is a 12-month temporary role, with huge probabilities of extension or turning into a permanent...

  • Senior Quality Control Analyst

    Vor 2 Tagen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    As a Senior Quality Control Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program. (This is a 12-month temporary role, with huge probabilities of extension or turning into a permanent...

  • Senior Quality Control Analyst

    Vor 2 Tagen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    As a Senior Quality Control Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program. (This is a 12-month temporary role, with huge probabilities of extension or turning into a permanent...

  • Senior Quality Control Analyst

    Vor 3 Tagen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    As a Sr QC Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program. Essential Job Functions: Performs analytical testing according to raw material and product release specifications (HPLC,...

  • Senior Quality Control Analyst

    Vor 4 Tagen

    2108 Couvet, Schweiz WuXi AppTec Vollzeit

    As a Sr QC Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program.Essential Job Functions:Performs analytical testing according to raw material and product release specifications (HPLC, GC,...

  • Manager Qc Analytical Science

    vor 4 Monaten

    Couvet, Schweiz WuXi AppTec Inc Vollzeit

    Overview: Quality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer. The position...

  • Senior Manager QA/RA Projects Lead

    vor 2 Wochen

    Couvet, Neuenburg, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    {"title": "Senior Manager QA/RA Projects", "content": "Job SummaryWe are seeking a highly experienced Senior Manager QA/RA Projects to join our team at STA Pharmaceutical Switzerland SA. As a key member of our Quality Leadership Team, you will be responsible for ensuring the quality and compliance of our products, as well as supporting our site in regulatory...

  • Senior Manager QA/RA Projects Lead

    vor 2 Wochen

    Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    {"Job Title": "Senior Manager QA/RA Projects", "Job Summary": "As a key member of the Quality Leadership Team, you will play a critical role in ensuring the quality and compliance of our products at the Couvet site. Your expertise in Quality Assurance and Regulatory Affairs will be instrumental in maintaining and improving our quality systems, ensuring cGMP...

  • QA Manager Npi

    vor 3 Monaten

    Couvet, Schweiz WuXi AppTec Inc Vollzeit

    Overview: QA NPI is responsible for supporting the entire Couvet site to ensure that each new product is manufactured, packaged, and tested in compliance with the GMP and according Product Owner. **Responsibilities**: - Act within the site's new product introduction projects teams as the main Quality Operations representative and single point of contact...

  • Senior Manager QA/RA Projects Lead

    Vor 3 Tagen

    Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    Job SummaryThis position is a safeguard and role model for the WuXi values and competencies. The successful candidate will be responsible for ensuring that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also support the site in the Company...

  • Senior Manager QA/RA Projects

    vor 2 Wochen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    Senior Manager QA/RA ProjectsOverviewThis position is a safeguard and role model for the WuXi values and competencies. Job Summary: This position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product...

  • Senior Manager QA/RA Projects

    vor 2 Wochen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    OverviewThis position is a safeguard and role model for the WuXi values and competencies. Job Summary: This position is responsible to support the entire Couvet site to ensure that each product is continuously manufactured, packaged, and tested in compliance with the Marketing Authorisation Dossier managed by the Customer/Product Owner and also to support...

  • Manager Bulk Operations Manufacturing

    vor 3 Monaten

    Couvet, Schweiz Wapt Vollzeit

    Overview: This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. **Job Summary**: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the...

  • Manager Bulk Operations Manufacturing

    vor 4 Monaten

    Couvet, Schweiz STA Pharmaceutical Vollzeit

    Overview: This position is a leadership role being responsible in direct management of individual contributors and/or supervisors and/or managers. This position is a safeguard and role model for the WuXi values and competencies. **Job Summary**: Lead the bulk operations and ensure that packaging goods are produced according to supply needs and as per the...

  • Packaging Operations Supervisor

    Vor 3 Tagen

    Couvet, Neuenburg, Schweiz WuXi AppTec Vollzeit

    Job Title: Supervisor Packaging OperationsWe are seeking a highly skilled and experienced Supervisor Packaging Operations to join our team at WuXi AppTec. As a key member of our packaging operations team, you will be responsible for overseeing the packaging activities of our products, ensuring compliance with GMP/cGMP regulations, hygiene rules, and safety...

  • Manager, Customer Service

    vor 2 Wochen

    Couvet, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    Manager, Customer ServiceOverviewIn this position the Manager, Customer Service can lead or participate to all sorts of cross-functional or improvement projects as it relates to supply Chain activities. In particular, transferring NPI projects from their development phase into commercial phase will be very typical for this function.This includes negotiating...

  • Customer Service Manager

    vor 2 Wochen

    Couvet, Neuenburg, Schweiz STA Pharmaceutical Switzerland SA Vollzeit

    Job DescriptionWe are seeking a highly skilled and experienced Customer Service Manager to join our team at STA Pharmaceutical Switzerland SA. As a key member of our supply chain team, you will be responsible for leading and participating in cross-functional projects related to supply chain activities.Your primary focus will be on transferring NPI projects...