Head of QA

Job Overview

JOB DESCRIPTION

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, 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 whilst ensuring strategy is effectively linked to long and short term business aims and objectives.

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

1. The manufacture of medicinal products for human use through:
2. Manufacturing and Importation Authorisation
3. Manufacture of Specials
4. Manufacture and Importation of Investigational Medicinal Products
5. 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 and manage the organisational structures, policies, procedures and processes necessary to ensure effective, efficient and accountable use of these resources.
• Assure compliance to all facilities, systems, processes and best work principles by maintaining a thorough quality oversight of internal site operations needed for the product manufacturing, testing and release.
• Develop, monitor, improve and maintain procedures to ensure compliance with EU / FDA Good Manufacturing Practice for the manufacture and testing of pharmaceuticals.
• Drive and oversee deviations, changes and CAPAs related to materials, facilities, processes or procedures are being escalated and addressed in an appropriate and timely manner.
• Providing QA leadership on the complaint delivery of key investigations.
• Manage and where applicable perform documentation reviews in accordance with relevant Standard Operating Procedures.
• Oversee batch release duties in accordance with relevant procedures, including issuing Certificates of Conformance for bulk drug product.
• Be accountable for on time document management and performance measurement.
• To immediately escalate any material breach of quality or regulatory compliance matters to the Site Director and Director of Quality Morpeth.
• Manage Quality Administration activities in accordance with business needs.
• Actively contribute to deliver the Quality strategy for the delivery of business effective compliant systems to support the operations and site processes.
• Support the site QP in the delivery of systems and batch documents which meet the requirements for batch release to market.
• To 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

• Must have extensive knowledge of Quality Assurance systems in the pharmaceutical industry.
• Relevant and proven management experience in an operational management role, operating to GMP standards and regulatory expectations.
• 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.
• An understanding of framework and interdependencies of regulatory affairs.

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.