Head of QA

Job Overview

This role has accountability for the management of the Quality Operational functions at Piramal Pharma Solutions Morpeth Site. The role will ensure that the Quality Assurance Operations team deliver the required support to ongoing manufacturing and batch release, together with providing QA leadership on continuous improvement of the process and quality standards on site. The role will maintain and develop the Quality Operations function in line with regulatory, industry, and corporate expectations while ensuring strategy is effectively linked to long and short term business aims and objectives.

Scope includes, but is not limited to:

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

Key Roles/Responsibilities

1. Recruit, lead, manage and develop the Quality Assurance department staff and manage the organisational structures, policies, procedures and processes necessary to ensure effective, efficient and accountable use of these resources.
2. Assure compliance to all facilities, systems, processes and best work principles by maintaining a thorough quality oversight of internal site operations needed for product manufacturing, testing and release.
3. Develop, monitor, improve and maintain procedures to ensure compliance with EU / FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals.
4. Drive and oversee deviations, changes and CAPAs related to materials, facilities, processes or procedures being escalated and addressed in an appropriate and timely manner.
5. Provide QA leadership on the complaint delivery of key investigations.
6. Manage and, where applicable, perform documentation reviews in accordance with relevant Standard Operating Procedures.
7. Oversee batch release duties in accordance with relevant procedures, including issuing Certificates of Conformance for bulk drug product.
8. Be accountable for on-time document management and performance measurement.
9. Immediately escalate any material breach of quality or regulatory compliance matters to the Site Director and Director of Quality Morpeth.
10. Manage Quality Administration activities in accordance with business needs.
11. Actively contribute to deliver the Quality strategy for the delivery of business effective compliant systems to support the operations and site processes.
12. Support the site QP in the delivery of systems and batch documents which meet the requirements for batch release to market.
13. Deputise where appropriate and undertake any other reasonable duties as requested by the Director of Quality Morpeth, in accordance with company requirements.

Qualifications

ESSENTIAL QUALIFICATIONS:

Degree in relevant scientific/technical discipline.

Ability to act as a QP in accordance with either the Human Medicines regulations or EU directive 2001/83/EC is preferred but not essential.

RELEVANT EXPERIENCE:

1. Must have extensive knowledge of Quality Assurance systems in the pharmaceutical industry.
2. Relevant and proven management experience in an operational management role, operating to GMP standards and regulatory expectations.
3. Relevant senior management experience within an EU/FDA approved pharmaceutical facility, including experience of hosting regulatory inspections (specifically MHRA and USFDA) and customer audits, championing a culture of compliance and driving continuous improvement.
4. An understanding of framework and interdependencies of regulatory affairs.