Position: CMO Quality Associate Manager
Location: Baddi
Industry Type: Pharma/ Healthcare/ Clinical research
Application End Date: 30th July 2024
Role Description: The CMO Quality Associate Manager is responsible for planning and managing quality oversight and operational quality activities for contract manufacturing organizations (CMOs) to meet compliance and business needs. This role involves working directly with internal and external stakeholders to provide quality and compliance leadership, routine support related to current commercialized products, and ensuring that the performance and quality of products conform to established standards and regulatory guidelines to ensure patient safety.
Key Responsibilities:
- Act as the single point of contact from the External Supply Quality team for external Contract Manufacturing Organisations (CMOs).
- Serve as the on-site quality representative at CMOs as required, and manage all quality records and documents related to CMO operations according to the respective quality system and Quality Agreement.
- Perform on-site investigations in case of market complaints and deviations for products manufactured at CMOs, and prepare/review investigation reports and proposed corrective and preventive actions.
- Prepare and maintain the Annual Product Quality Reviews schedule/calendar for products manufactured at CMOs.
- Drive timely periodic risk assessments of CMOs, ensuring compliance and implementing appropriate corrective and preventive actions.
- Develop and maintain Quality Technical Agreements.
- Evaluate and present monthly CMO quality metrics for management oversight review.
- Participate in and support cross-functional teams regarding product investigations, regulatory audits/inquiries, implementation of new/revised GxP guidelines, and improvement initiatives.
- Implement appropriate standards and practices for the quality of contract manufacturing operations.
- Manage the risk assessment process for CMOs and lead efforts to execute risk mitigation plans.
- Provide QA support for interdepartmental project work to ensure on-time deliverables.
- Support product transfers, coordinate with CMO and Central Quality for compliance and support during the manufacturing of commercial scale/process validation batches.
- Perform additional tasks as assigned by the Head of ESQ India.
Candidate Profile:
- Minimum Qualification: Bachelor of Pharmacy, Bachelor of Technology in Biotechnology, or Master’s in Science (Chemistry).
- Minimum of 8+ years of experience in the pharmaceutical/biopharmaceutical industry, medical, or life sciences required.
- Demonstrated ability to work across a matrix organization in an international and multi-cultural environment.
- Preferred experience working with external partners (e.g., contract manufacturing organizations, contract laboratories, and suppliers).
- Good understanding of external compliance trends and ability to address needs based on external demand.
- Strong technical writing and project management skills.
- Strong analytical and problem-solving skills to troubleshoot experimental issues and propose solutions.
- 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.
- Fluency in English is required.
How to Apply: Interested candidates can apply by [inserting application method/link here].
Feel free to adjust the contact method or any other details as needed.