Manager Development Quality Assurance (BRDS)

Date : 12 Aug 2025

Location :

Bangalore, KA, IN, 560099

Custom Field 1 : Essential Functions

Role : Development Quality Assurance

Department : Discovery and Development QA

Job Location : Bengaluru, India

About Syngene : Syngene International Ltd. (BSE : 539268, NSE : SYNGENE, ISIN : INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene's 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq. ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.

Key Result Areas : We are seeking an experienced and dynamic Quality Assurance lead to manage research and development quality assurance division at Syngene. This role will involve implementing Syngene Quality Assurance principles for Biologics development and ensuring compliance to quality systems throughout the life cycle of R&D projects.

Mandatory expectation

• Responsible and accountable towards safety and compliance in all the work activities in the own responsibility area(s).
• Monitor and confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self and direct reports.
• Monitor and confirm that self and direct reports adhere to the highest standards of quality, integrity and compliance for every work activity.
• Complete the assigned training in a timely manner and comply with the training procedure and training calendar and monitor and confirm the same for the direct reports.
• Attend all assigned mandatory training related to data integrity, health and safety measures, and monitor and confirm the same for the direct reports.
• Participate and support the training on procedures, protocols and On-the-Job activities.
• Comply with Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
• Report nonconformities and deviations to the respective supervisor(s) and / or line manager(s).
• Participate and support on-time initiation and closure of deviations, investigations, CAPA and change controls.

Educational Qualification : Masters or Doctorate degree in Pharmaceuticals, Biotechnology, Engineering or any stream of science.

Profile Description : This role will be responsible for crafting the allocation methodologies and process flows for Development services. This individual will collaborate actively with Operation units of development services for one of our clients to improve alignment and achievement of customer satisfaction and value realization

Core Purpose of the Role : Responsible for Quality Systems of Development Services and relevant QA activities.

Role Accountabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

Excellence

Integrity

Professionalism

Experience : 10+ years of experience in driving quality assurance in pharmaceutical / biopharmaceutical industry

Skills And Capabilities

Equal Opportunity Employer : It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and / or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities

Skills Required

Biologics development process flow, Electronic notebooks, TrackWise QMS Software