Manager, Quality Assurance – R&D Digital Transformation

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:

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

Experience:

- 15 years or more in 15+ Years

Specialized Knowledge: Licenses: