Assistant General Manager Quality Control

Job Description

Role Objective

A key objective of this position is to serve as a strategic leader by providing scientific, technical, and managerial expertise in Quality Control (QC) and Analytical Development across diverse product portfolios. The position is responsible for establishing, validating, and implementing robust analytical testing methodologies in alignment with global regulatory requirements. In addition, the role emphasizes driving operational excellence, ensuring regulatory compliance, and fostering a culture of continuous improvement within the organization.

Desired Candidate Profile

- Graduate/Postgraduate in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Minimum 1822 years of relevant experience in Quality Control and Analytical Development, with at least 45 years in a leadership capacity.
- Strong knowledge of cGMP, FDA, ICH, and other applicable regulatory guidelines.
- Proven expertise in method development, validation, transfer, and technology transfer.
- Demonstrated ability to lead cross-functional teams, manage budgets, and oversee multi-site QC operations.
- Excellent interpersonal, communication, and leadership skills.

Roles & Responsibilities

- Lead QC and Analytical Development operations across sites, ensuring compliance with cGMP and regulatory requirements.
- Establish, validate, and maintain analytical testing methodologies for raw materials, intermediates, excipients, APIs, and drug products.
- Oversee the development of specifications, stability programs, trend analyses, and retesting strategies.
- Ensure effective implementation and continuous utilization of Laboratory Information Management Systems (LIMS).
- Provide scientific guidance for investigations and resolution of OOS (Out-of-Specification) and OOT (Out-of-Trend) results while ensuring data integrity.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing to ensure robust analytical support for product development and commercial operations.
- Develop SOPs and ensure all quality control documentation aligns with regulatory standards.
- Drive method improvement, method transfer, and technology transfer initiatives.
- Monitor equipment qualification, calibration, and compliance with analytical testing requirements.
- Manage budgets, forecast expenditures, and allocate resources efficiently.
- Lead, mentor, coach, and develop the QC and Analytical Development team to enhance technical competencies and scientific excellence.
- Support production processes through analytical insights and data-driven decision-making.

Functional Skills Required

- Strong expertise in analytical techniques (UV, Dissolution, etc.).
- Knowledge of compendial requirements (USP, EP, JP, BP, etc.).
- Competency in method development, validation, and lifecycle management.
- Proficiency in data integrity principles and LIMS implementation.
- Ability to conduct and review technical investigations with root cause analysis.
- Budget planning and resource management.

Behavioral Skills Required

- Strategic mindset with a results-oriented approach.
- Strong problem-solving and decision-making skills.
- Excellent leadership and people management capabilities.
- Ability to influence and collaborate across cross-functional teams.
- Adaptability to a fast-paced, evolving environment.
- Commitment to scientific excellence and continuous improvement.

Team Size to be Handled:

Manage a team of 20-25 QC professionals, including 3-4 direct reportees at the Sr. Manager and Manager levels, reporting to the VP Corporate Quality.

Important Links:

Website:https://biotechhealthcare.com/

LinkedIn:https://www.linkedin.com/company/biotechhealthcare/

Instagram:Biotech Vision Care

Biotech is an Equal Opportunity Organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.