Senior Manager - Cluster Support (API

Job Title:

Sr.Manager Cluster Support - API (QA)

Business Unit:

Global Quality & Compliance

Job Grade

G9A

Location :

Baroda / Mumbai

The Senior Manager API Cluster Support is responsible for ensuring compliance with cGMPs and GLPs across all API manufacturing sites. The person shall have experience in API QC & QA background, which includes exposure in handling of production manufacturing investigations, computer system validations expertise, and also exposure to Quality Control experience, taking care of all QC investigations. This role involves monitoring and improving quality systems, facilitating quality management reviews, and driving continuous improvement initiatives.

The position also supports regulatory audits, coordinates corrective actions, and addresses critical quality issues to maintain operational excellence and regulatory compliance.

• Vendor Management
• Monitor compliance with cGMPs, GLPs, and regulatory requirements across API sites.
• Resolve escalated quality issues and support corrective actions and process improvements.
• Conduct weekly calls to track compliance actions from regulatory inspections and internal/customer audits, cascading learnings across sites.
• Coordinate with R&D to track pending actions related to Nitrosamine assessment, Genotoxic assessment, Cleaning methods (HPLC vs. UV), UV absorbance methods, and Method validations (KSM, intermediates).
• Ensure completeness and reassessment of nitrosamine and genotoxic data as per current regulatory expectations.
• Vendor Management

• Monitor and track QMS performance to optimize extension.

• Participate in site and corporate QMRs.
• Collect and summarize cluster-level data for management review meetings.
• Implement improvements to standardize processes across API sites.

• Align site procedures with global quality standards and corporate policies (GQS and GSOP Implementation).

• Lead initiatives to enhance compliance, efficiency, and cost-effectiveness.

• Support internal and external audits, including remediation plan execution.
• Coordinate audit responses and ensure effective resolution of observations.

• Track QA/QC metrics and ensure timely action on deviations.

• Conduct gap analyses and implement strategies to close gaps and improve system performance.

• Stay updated on regulatory changes and industry trends to identify improvement opportunities.

• Coordinate quality improvement efforts across API sites to ensure consistent implementation of global actions.

• Continuously monitor and track site QMS pendency and LIMS template pendency to proactively prevent regulatory or internal audit observations.
• Timely escalate long-pending QMS records and support site teams to ensure closure within defined timelines.

• Ensure close collaboration with the Quality IT team to support CFR Part 11 and Annex 11 compliance across all applicable systems.
• Ensure compliance of laboratory IT systems such as Empower, LabX, and Lab Solution with enterprise-level requirements.

• Ensure robust oversight and compliance in key laboratory areas, including:
• Unconfirmed OOS investigations
• Laboratory events and deviations
• Method validation for analytical procedures
• Cleaning validation including analytical methods and alignment with GSOP and GQS requirements
• Implementation of GSOPs and GQS standards across laboratory operations
• Monitoring OTIF (On-Time In-Full) and SLA (Service Level Agreements) to ensure timely and quality deliverables

Educational Qualification

B.Pharm / M.Pharm

Experience

Tenure :14+ years

Disclaimer:
The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.