QC Operations Manager
vor 4 Wochen
Position Overview
About the Opportunity:
We invite you to become a vital member of our team as a Quality Control Supervisor at Takeda. In this influential role, you will be instrumental in maintaining the precision and effectiveness of our laboratory functions. Working in close partnership with the Quality Control Manager, you will ensure the prompt provision of testing outcomes while adhering to the utmost quality management standards. This position also allows you to take on managerial responsibilities, offering essential support and facilitating the smooth operation of our quality assurance workflows. If you are dedicated to excellence in laboratory practices and thrive in a collaborative setting, this opportunity is designed for you.
Your Contributions:
- Oversee the analysis of in-process samples, raw materials, and final products in compliance with Standard Operating Procedures (SOPs) and regulatory standards.
- Act as a champion for laboratory safety and security protocols.
- Evaluate testing methodologies and ensure the accuracy and completeness of all documentation.
- Lead, mentor, and supervise a team of Quality Control analysts, ensuring the successful completion of annual performance evaluations.
- Address issues related to laboratory equipment and methodologies.
- Ensure the calibration and upkeep of laboratory instruments.
- Promote continuous improvement initiatives within the laboratory environment.
- Manage deviations and investigations, and support the implementation of Corrective and Preventive Actions (CAPA).
- Conduct change assessments as necessary.
- Maintain audit readiness within the laboratory, including preparation and presentation during audits.
- Supervise and engage in laboratory validation activities.
- Guarantee the timely availability of necessary testing capabilities and related documentation.
- Ensure compliance regarding the status of equipment and procedures.
Your Qualifications:
- A Master’s degree (or equivalent) or a minimum of 10 years of experience in the pharmaceutical sector, ideally within a Biologics organization.
- Proven ability to manage multiple priorities and recognize when to escalate issues for resolution.
- Strong understanding of Good Manufacturing Practices (GMP), International Council for Harmonisation (ICH), United States Pharmacopeia (USP), and global regulatory guidelines.
- Demonstrated experience with continuous quality and process improvement methodologies.
- A strategic mindset to prioritize effectively within the laboratory setting.
- Ability to work collaboratively across functions, focusing on adherence to schedules and fostering an interdependent work culture.
- Experience in people management, showcasing strong interpersonal skills to effectively lead and support the QC analyst team, while implementing proactive conflict resolution and employee development strategies.
- Excellent communication skills with both customers and suppliers.
- Strong project management capabilities to facilitate project delivery and operational readiness.
- Exceptional troubleshooting and problem-solving skills, with a capacity to coach and mentor teams through complex challenges.
- In-depth knowledge of FDA, EMA, ICH regulations, and quality system standards.
- Familiarity with inspections against regulatory and quality standards.
- Proficient computer skills.
- Fluency in both French and English (B2 level, written and spoken).
What Takeda Offers:
We provide competitive salaries, comprehensive accident coverage, contributions to health insurance premiums, attractive pension plans, subsidized meals, and financial support for employee sports activities. Additionally, we assist with local public transport passes, offer free parking, and have a car-sharing program.
At Takeda, we are committed to creating a supportive working environment that prioritizes the well-being, safety, development, and career progression of our employees.
About Takeda:
At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs. As a patient-focused organization, we inspire and empower our employees to grow through impactful work.
Recognized as a Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors. We cultivate an inclusive and collaborative workplace, united by a shared commitment to delivering Better Health and a Brighter Future for people worldwide.
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