CMO Quality Associate Manager

Job Title: CMO Quality Associate Manager

Job Location: Baddi

Role Description

Responsible for planning and managing the Quality oversight & operational quality activities for contract manufacturing organizations (CMOs) to meet Quality compliance and business needs. This position will also work directly with internal and external stakeholders to provide sustaining quality and compliance leadership, routine support related to current commercialized products. Ensures that performance and quality of products conform to established standards and regulatory guidelines to ensure patient safety.

·       Single Point of Contact from External Supply Quality team of company for external Contract Manufacturing Organisation(s).

·       On-site Quality person of our company at CMOs (as & when required), visits to CMO’s from time-to-time basis as per requirements. Manage all quality records & documents related to CMO according to respective quality system, Quality Agreement and ensure the compliance (i.e., Deviation, Change Control, Investigation, CAPA’s etc).

·       Performing on-site investigations in-case of Market Complaints, deviations for products manufactured at CMOs. Preparation and /or review of investigation report and proposed Corrective and Preventive action (if any), verification of Corrective and Preventive action implemented at CMOs and effectiveness checks.

·       Preparation of Annual Product Quality Reviews schedule/calendar for the year and ensuring the availability of Product Quality Review reports for products manufactured at CMOs as per PQR Calendar.

·       Drive timely periodic risk assessment of CMOs and ensures the compliance and appropriate corrective & preventive actions are identified and implemented wherever required.

·       Responsible for development and maintenance of Quality Technical Agreements.

·       Evaluates and presents monthly CMO quality metrics for management oversight review.

·       Participating in and providing support to cross-functional teams in relation to product investigation, regulatory audits/inquires, implementation of new/revised GxP guidelines and improvement initiatives.

·       Implementing appropriate standards and practices for quality of contract manufacturing operations. 

·       Manages risk assessment process for CMOs and leads efforts to execute risk mitigation plans.

·       Provide QA support for interdepartmental project work to ensure on-time deliverables. Providing support in preparation and review of process validations protocols & reports as per validation activity & follow-up for closure of deviations if any, data collection of validation product from CMOs.

·       Supporting Product Transfers, Co-ordinate with CMO and Central Quality for quality compliance and support, during manufacturing of commercial scale / process validation batches. Ensure timely review of documents / results for final release of batches.

·       To perform additional tasks as assigned by Head of ESQ India.

Job Requirements

·       Minimum Qualification - Bachelor of Pharmacy/ Bachelor of Technology- Biotechnology / Master’s in science (Chemistry)

·       Minimum 8+ years of experience in the pharmaceutical / biopharmaceutical industry, medical, or life sciences required.

·       Demonstrated ability to work across matrix organization in international and multi-cultural environment. Experience working with external partners (e.g. contract manufacturing organizations, contract laboratories and suppliers) is preferred

·       Good understanding of external compliance trends and ability to address needs based on external demand, strong knowledge of technical writing and project management skills.

·       Strong analytical and problem-solving skills to troubleshoot experimental issues and propose solutions to challenges.

·       Excellent written and verbal communication skills to present findings, write reports, and collaborate with team members and other stakeholders.

·       Flexibility and adaptability to handle unexpected challenges and adjust strategies accordingly.

·       Fluent in English