Manager, Quality Assurance R&D Digital Transformation

Job Description

JOB DESCRIPTION

• Review product development strategies to ensure compliance with current regulatory requirements, industry expectations, and quality standards.
• Review formulation development reports to verify data integrity, traceability, accuracy, and compliance with laboratory notebooks, raw data, and supporting documents.
• Manage issuance, control, reconciliation, and maintenance of laboratory notebooks and associated records. Coordinate with Formulation Development, Analytical Development, Regulatory Affairs, and other cross-functional teams for preparation and review of scientific responses to regulatory queries, including USFDA Screening Queries, Information Requests (IR), ECD/EDL communications, Complete Response Letters (CRL), and other agency communications.
• Provide quality assurance inputs in Design Space and Quality by Design (QbD) activities to strengthen development reports and regulatory submissions.
• Develop and maintain a database of regulatory deficiencies, agency responses, historical observations, and anticipated queries to support robust development strategies.
• Review and approve development-related documentation to ensure compliance with internal procedures and applicable regulatory requirements.
• Review documents related to instrument qualification, calibration, maintenance, and equipment lifecycle management as required.
• Control issuance, review, revision, and archival of formulation development documents and records.
• Monitor archival, retention, retrieval, and management of departmental documents in accordance with company procedures.
• Act as the departmental coordinator for Quality Management Systems (QMS), including Cliber, AIMS, DMS, and other electronic quality systems.
• Provide QA oversight and support for packaging development activities whenever required.
• Ensure adherence to Data Integrity, Good Documentation Practices (GDP), Quality Systems, and applicable regulatory expectations.
• Promote and enforce the organization's Code of Conduct, quality culture, ethics, safety, hygiene, and compliance standards across the department.
• Support inspection readiness and participate in internal, customer, and regulatory audits as required. Collaborate with cross-functional teams to identify quality risks and implement appropriate corrective and preventive actions.
• Drive continuous improvement initiatives related to development quality systems, documentation practices, and regulatory compliance.
• Proficiency in Microsoft PowerPoint for preparation of professional scientific, quality, regulatory, and management presentations.
• Strong digitalization mindset with experience in electronic quality systems, digital workflows, process automation, data analytics, and dashboard development (Power BI, Excel advanced analytics, or similar tools preferred).
• Effective communication, presentation, and stakeholder management skills.
  
  

Education

QUALIFICATIONS

• B. Pharm M. Pharm - Required
• Ph. D. Ph. D. - Preferred
  
  

Experience

• 15 years or more in 15+ Years
  
  

Specialized Knowledge: Licenses:

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.