Head of Quality Control Operations
vor 2 Monaten
About the Role:
As a key member of the Takeda team, you will be responsible for directing the Quality Control Laboratories in a large size plant and leading a large department to support Facility, Division, and Corporate-wide initiatives.
Key Responsibilities:
- Develop and deploy quality systems to ensure products conform to defined requirements.
- Understand and deploy processes to assure conformance to regulations.
- Manage interactions with customers and regulators concerning the quality of products, systems, and processes.
- Oversee the development and implementation of standards, methods, procedures, and sampling for inspection, testing, and evaluating the precision, accuracy, and reliability of the product.
- Member of the Quality Lead Team.
- Ensure that products tested on behalf of other Takeda facilities meet with the agreed customer timelines and aligned with OTIF requirements.
- Promote all actions that make lab operations safe, reliable, compliant, and aligned with standard times.
- Ensure that all Out Of specification or significant atypical trends are investigated and any confirmed out of specification result, or significant negative trend, affecting product batches released on the market are reported to escalate accordingly.
- Own personal accountability for all EHS aspects, ensuring the team is operating in a safe work place.
Requirements:
- In-depth knowledge of the regulatory environment for manufacture of biological products, including strong knowledge of FDA, EMA, and ICH regulations and USP, EP, JP, and ChP requirements.
- Master's degree in Science (Microbiology and Chemistry) with more than 15 years of experience in the Pharmaceutical industry, 10 years in Quality Control, and 2 years in Production, with 15 years of management experience.
- Strong drive for continuous improvement activities within the lab.
- Strong leadership skills and demonstrated success in managing a large team.
- Ability to build layers of succession within the organization and a talent pipeline.
- Strong analytical and problem-solving skills, excellent verbal and written communication skills, and success working with multifunctional, cross-facility global teams.
- Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
- Must have passion to innovate and drive for solutions, must display personal accountability for results and integrity.
- Must display eagerness to learn and continuously improve, must have uncompromising dedication to quality.
- Must have relentless focus on rapid and disciplined action, must have respect for individuals and the diverse contributions of all.
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