Head of QA

Piramal Pharma Ltd; Morpeth; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance Manager to oversee operations at their Morpeth site. The role involves managing the QA team, ensuring compliance with regulatory standards, and leading continuous improvement initiatives. Ideal candidates will have extensive experience in the pharmaceutical industry and a relevant degree. This position offers the opportunity to contribute to a culture of quality and compliance in a dynamic environment.

Qualifications

• Extensive knowledge of Quality Assurance systems in the pharmaceutical industry.
• Proven management experience in an operational GMP environment.

Responsibilities

• Manage the Quality Assurance department staff and ensure compliance with quality standards.
• Oversee batch release duties and ensure timely document management.
• Provide QA leadership on key investigations related to complaints.

Skills

Quality Assurance

Regulatory Compliance

Continuous Improvement

Education

Degree in a relevant scientific or technical discipline

Job description

Job Overview

This role has accountability for managing the Quality Operational functions at Piramal Pharma Solutions Morpeth Site.

The role will ensure that the Quality Assurance Operations team provides the necessary support for ongoing manufacturing and batch release, while also leading continuous improvement of processes and quality standards on site.

The role will maintain and develop the Quality Operations function in line with regulatory, industry, and corporate expectations, ensuring that strategies are effectively aligned with long and short-term business objectives.

Scope includes, but is not limited to, ensuring the proper application of:

• The manufacture of medicinal products for human use through:
• Manufacturing and Importation Authorization
• Manufacture of Specials
• Manufacture and Importation of Investigational Medicinal Products
• Acting as the Quality and regulatory focus for products manufactured under Morpeth Marketing Authorization Holder (Project Agile)

Key Roles/Responsibilities

• Recruit, lead, manage, and develop the Quality Assurance department staff, managing organizational structures, policies, procedures, and processes for effective resource use.
• Ensure compliance with all facilities, systems, processes, and principles by maintaining thorough quality oversight of internal site operations related to manufacturing, testing, and release.
• Develop, monitor, improve, and maintain procedures to ensure compliance with EU / FDA Good Manufacturing Practice for pharmaceuticals.
• Oversee deviations, changes, and CAPAs related to materials, facilities, processes, or procedures, ensuring they are addressed promptly.
• Provide QA leadership on key investigations related to complaints.
• Manage and review documentation in accordance with Standard Operating Procedures.
• Oversee batch release duties, including issuing Certificates of Conformance for bulk drug products.
• Ensure timely document management and performance measurement.
• Escalate any material breach of quality or regulatory compliance to the Site Director and Director of Quality Morpeth immediately.
• Manage Quality Administration activities as per business needs.
• Contribute to the delivery of the Quality strategy to support compliant systems and site processes.
• Support the site Qualified Person (QP) in delivering systems and batch documents that meet batch release requirements.
• Act as deputy and undertake other duties as requested by the Director of Quality Morpeth, in line with company requirements.

Qualifications

Essential Qualifications:

• Degree in a relevant scientific or technical discipline.
• Ability to act as a QP under Human Medicines regulations or EU directive 2001/83/EC is preferred but not essential.

Relevant Experience

• Extensive knowledge of Quality Assurance systems in the pharmaceutical industry.
• Proven management experience in an operational GMP environment, compliant with regulatory standards.
• Senior management experience in an EU/FDA approved pharmaceutical facility, including hosting regulatory inspections and audits, and fostering a culture of compliance and continuous improvement.
• Understanding of regulatory affairs frameworks and interdependencies.

About Us

Piramal Group has grown organically and through acquisitions over three decades, guided by core values of inclusive growth and ethical practices.

Equal Employment Opportunity

Piramal Group is an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, gender, sexual orientation, age, disability, or other protected characteristics. Employment decisions are based on merit, qualifications, skills, and performance.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end solutions across the drug development and manufacturing spectrum, with facilities worldwide. PPS offers services including drug discovery, process development, clinical trial supplies, and manufacturing of APIs, finished dosage forms, biologics, and more, serving innovators and generic companies globally.