Maxis Clinical Sciences - Quality Site Head - Formulations - OSD

Job Title: Quality Site Head - Formulations (OSD)

Location: Daman

Industry: Pharmaceuticals (Formulations)

Job Title: Quality Site Head Formulations (OSD)

Location: Daman

Industry: Pharmaceuticals (Formulations)

Job Description:

We are seeking a highly experienced and dynamic Quality Site Head to lead the Quality Assurance (QA) function at our clients state-of-the-art formulations manufacturing site. This role is pivotal in ensuring the highest standards of compliance, product quality, and operational excellence, specifically within the Oral Solid Dosage (OSD) domain.

Key Responsibilities:

Quality Leadership:

- Oversee the entire Quality Assurance (QA) function at the site, ensuring adherence to cGMP, regulatory standards, and company policies.

- Lead, mentor, and manage a team of 300-400 professionals, fostering a culture of quality and compliance.

Regulatory Compliance:

- Develop and implement robust strategies to ensure seamless compliance with global regulatory requirements, including but not limited to USFDA, MHRA, and other relevant authorities.

- Prepare for and manage regulatory inspections and audits, addressing any findings promptly.

Operational Excellence:

- Collaborate with cross-functional teams, including production, R&D, and supply chain, to ensure the delivery of high-quality products.

- Drive continuous improvement initiatives to enhance product quality, reduce deviations, and streamline quality processes.

Stakeholder Management:

- Act as a key liaison with regulatory bodies and internal/external stakeholders, ensuring clear communication and effective resolution of quality-related matters.

- Provide strategic direction to senior leadership on quality-related risks and opportunities.

Desired Candidate Profile:

Education: Bachelors/Masters degree in Pharmacy, Pharmaceutical Sciences, or a related field.

Experience:

- Minimum of 15+ years of experience in Quality Assurance within the pharmaceutical industry, with a strong focus on Oral Solid Dosages (OSD).

- Proven track record of leading a manufacturing sites QA function, managing large teams (300-400 people), and ensuring compliance with global regulatory standards.

Regulatory Expertise:

- Hands-on experience in handling regulatory inspections and audits by USFDA, MHRA, and other international agencies.

Leadership Skills:

- Strong leadership, decision-making, and team management capabilities.

- Ability to drive a culture of quality, accountability, and continuous improvement.

Why Join Us?

- Be part of a globally recognized pharmaceutical company known for its innovation and commitment to quality.

- Opportunity to lead a highly skilled team and contribute to strategic decisions at a senior level.

- Competitive compensation package of up to 1.10 Cr per annum along with other benefits.