Quality Control Senior Manager
2 weeks ago
Our client, a prominent player in the life sciences sector, is focused on the development and commercialization of advanced technologies for the manufacturing and detection of nucleic acids. They are currently seeking a Senior Manager of Quality Control to join their team.
This role is pivotal in steering the quality control laboratory operations, ensuring compliance with ISO13485 and cGMP standards while transitioning from a foundation rooted in industrial product quality control. The ideal candidate will possess a strong background in biopharmaceuticals, life sciences, or biotechnology.
Key Responsibilities:- Lead the Quality Control team, ensuring adherence to ISO9001, ISO13485, and cGMP quality systems.
- Conduct hands-on testing utilizing advanced techniques such as high-performance liquid chromatography, gas chromatography, and more.
- Develop, validate, and document analytical methods and standard operating procedures tailored to specific testing requirements.
- Oversee outsourced testing resources for analytical assays, ensuring quality and efficiency.
- Analyze data and prepare comprehensive scientific reports.
- Qualify new instruments and manage preventive maintenance programs.
- Collaborate cross-functionally with manufacturing, R&D, and sales to ensure compliance with quality and regulatory standards.
- Assist in regulatory inspections and customer interactions.
- Manage laboratory equipment procurement and maintenance.
- Maintain thorough documentation as per standard operating procedures.
The successful candidate will possess:
- A minimum of 5 years of experience in quality operations within the biopharma or pharmaceutical industry.
- A Master’s degree in biology, molecular biology, chemistry, or a related life science field; a PhD is advantageous.
- Expertise in nucleic acid manufacturing and quality method development.
- Experience with environmental monitoring and microbiological assays.
- Familiarity with quality systems such as ISO9001, ISO13485, and cGMP.
- Strong organizational and communication skills, with a collaborative mindset.
- A commitment to laboratory safety and regulatory compliance.
- A passion for innovative science and a desire to contribute to advancements in genetic medicine.
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