Quality Control Manager - OSD Formulation - Pharma

Position Summary:

We are seeking an experienced and highly skilled Quality Control (QC) Manager to lead our QC team. The ideal candidate will have a minimum of 12 years of QC experience, with at least 5 years in a people management role. The QC Manager will oversee all QC operations, ensuring compliance with regulatory standards and contributing to the continuous improvement of our processes. Experience with audits and regulatory inspections is essential.

Key Responsibilities:

Leadership and Management:

- Lead and mentor the QC team, fostering a culture of excellence, collaboration, and continuous improvement.

- Manage team performance, provide training and development opportunities, and conduct regular performance reviews.

Quality Control Operations:

- Oversee all QC activities, including raw material, in-process, and finished product testing to ensure compliance with internal and external standards.

- Develop, implement, and maintain QC protocols and procedures.

Regulatory Compliance:

- Ensure compliance with all relevant regulatory requirements, including FDA, EMA, and other international standards.

- Lead and prepare for regulatory inspections and audits, and effectively address any findings.

Continuous Improvement:

- Drive initiatives to improve QC processes, enhance efficiency, and reduce costs.

- Implement new technologies and methodologies to stay at the forefront of industry best practices.

Documentation and Reporting:

- Ensure accurate and timely documentation of all QC activities.

- Prepare and present reports on QC performance, trends, and metrics to senior management.

Collaboration:

- Work closely with other departments, including Production, R&D, and Regulatory Affairs, to ensure seamless integration of QC processes.

- Serve as a key point of contact for internal and external stakeholders on QC matters.

Qualifications and Experience:

- Bachelor's degree in Chemistry, Pharmacy, or a related field. Advanced degree preferred.

- Minimum of 12 years of experience in Quality Control within the pharmaceutical industry, specifically with oral solid dosage (OSD) forms.

- At least 5 years of experience in a managerial role, with a proven track record of effective people management.

- Extensive experience with regulatory audits and inspections.

- In-depth knowledge of GMP, FDA, EMA, and other relevant regulations.

- Strong leadership, communication, and interpersonal skills.

- Proficiency in QC software and tools.

Skills and Competencies:

- Exceptional problem-solving and analytical skills.

- Ability to work under pressure and manage multiple priorities.

- Strong organizational and project management skills.

- Commitment to maintaining the highest standards of quality and compliance.