Head of Quality Control /Analytical Development

Job Scope:

The Head of QC/ AD will be responsible for leading the QC/AD team in ensuring that all in-process samples and final products meet established quality and regulatory standards within a biotechnology or pharmaceutical setting. This role will focus on analytical testing, method validation, and compliance with Good Manufacturing Practices (GMP).

Essential responsibilities:

Quality Control (QC):

• Oversee day-to-day operations of the QC laboratory, Stability, and Sample & Data Management groups ensuring compliance with cGMP, FDA, and other regulatory requirements.
• Develop and implement QC strategies, analytical methods, and quality control processes for biologics, cell and gene therapy, or pharmaceutical products.
• Manage QC testing for in-process controls and finished products, ensuring accuracy and reliability.
• Lead method validation, stability studies, and assay development activities in accordance with regulatory expectations.
• Support regulatory submissions, audits, and inspections, ensuring all quality control activities align with compliance standards.
• Collaborate with cross-functional teams, including Quality Assurance (QA), Manufacturing, and R&D, to resolve quality-related issues

Analytical Development (AD):

• Oversee development, qualification, and transfer of analytical methods for biologics, viral vectors, or cell therapy products.
• Lead implementation of analytical platforms including HPLC/UPLC, CE, ELISA, qPCR/ddPCR, flow cytometry, etc.
• Approve and review analytical protocols, development reports, method validation protocols, and transfer documentation.
• Provide scientific and regulatory support for client projects, including IND/BLA/MAA submissions.

Team & Strategic Leadership:

• Build, mentor, and manage high-performing QC/AD teams to support multiple concurrent programs.
• Lead all QC operations, including raw material, in-process, release, and stability testing.
• Develop department goals, operational metrics, and resource plans to support corporate and client project timelines.

Provide strategic input into quality and analytical capabilities expansion, including equipment, digital tools, and automation.

Qualifications: 

• Bachelor's or advanced degree in Biochemistry, Microbiology, Biotechnology, or a related field.
• 8+ years of relevant experience in biopharmaceutical quality control and analytical development, with around 5 years in a leadership role.
• Strong knowledge of cGMP, ICH guidelines, and regulatory requirements for biologics, pharmaceuticals, or advanced therapies.
• Hands-on experience with analytical techniques such as HPLC, ELISA, PCR, Flow Cytometry, and Cell-Based Assays.
• Proven leadership skills with experience in managing QC or AD teams
• Excellent problem-solving, organizational, and communication skills.

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