Aktuelle Jobs im Zusammenhang mit Quality Assurance Manager - Neuenburg, Neuenburg - Takeda
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Quality Assurance Manager
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Senior Quality Assurance Expert
vor 4 Wochen
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Quality Assurance Manager
vor 2 Monaten
About the Role:
An exciting and challenging opportunity has become available at Takeda for a Quality Assurance Manager, within the Quality Assurance Department.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement-minded and change-agile professional to embrace a team-based culture and more specifically within the Quality Unit team within a world-class Biotech manufacturing environment.
The scope of the role is to manage the day-to-day and the medium to long-term operations related to Quality Control and Raw Material activities related to sterile biologic products manufacturing, ensuring compliance with the license, regulations as well as cGMP Regulations.
Key Responsibilities:
- Ensure the day-to-day quality oversight of the Quality Control activities and Raw Material management related to his/her scope of responsibility.
- Ensure raw material release and manages specifications.
- Collaborate with suppliers to address quality issues and implement corrective action plans.
- Responsible for the effective management of the quality systems operating in his/her scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance.
- Support the Quality on the Shop Floor culture.
- Provide direction in the event of manufacturing incidents that may potentially affect quality or compliance.
- Ensure that deviations and complaints are investigated, reports are available.
- Ensure that escalation mechanisms as defined in site regulations are being adhered to.
- Supervise ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas in the successful performance of these activities.
- Ensure a constant alignment with his/her QA peers to provide a consistent quality support to the entire Neuchâtel site and beyond.
- Cultivate a smooth and collaborative partnership with his/her local and global business partners (i.e., Laboratories, Supply Chain, Manufacturing).
- Contribute to site strategic projects and objectives.
- Contribute that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her group are provided in a timely manner and with appropriate level of quality.
- Represent area of responsibility internally and externally.
- Act as QP delegate and perform all related activities including batch disposition.
- Manage a team of about 10 people and conduct Compensation reviews, Performance Review Conversations, Setting of Objectives, Development Plans.
- Manage the resources to ensure medium to long-term partmental objectives and time scales are achieved.
- Own personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe workplace.
- Drive continuous improvement and Lean Culture.
Requirements:
- University degree in Life Science.
- Minimum 5-10 years of experience in sterile and/or biological products pharmaceutical industry with extensive experience in Quality Control operations.
- At least 5 years of experience in people management.
- Good knowledge of method validation/verification and equipment/software validation requirements.
- Excellent knowledge of cGMP/GLP.
- Experience of aseptic filling under isolator and of visual inspection is highly appreciated.
- Qualified Person/delegate experience is a plus.
- Fluent English (C1) and French (min B2) is a must.
