External Quality Assurance Manager

External Quality Assurance Manager - Breda, Netherlands - Full-time - Hybrid - 3 days in the office and 2 days working from home.

About the Company

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally by revitalising niche, tried-and-trusted medicines. Since our inception in 2013, we have grown consistently year on year, delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide. We are an agile, committed and innovative global speciality pharmaceutical business and a preferred partner for innovator pharmaceutical companies. We are passionate about unlocking the potential of established medicines, engaging with clinical communities and creating sustainable value through effective lifecycle management and innovation. Our therapeutic areas include Cardiovascular, Oncology, Endocrinology and Neurology.

About the Role

We are looking for an experienced External Quality Assurance Manager to provide quality oversight and governance of third-party manufacturing and supply partners, including Contract Manufacturing Organisations (CMOs) and Contract Development and Manufacturing Organisations (CDMOs). This role will play a key part in ensuring that our external partners operate in accordance with applicable Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Quality Technical Agreements, internal procedures and regulatory expectations. We will focus particularly on biological products and biosimilars, covering drug substance and drug product manufacturing, testing, storage, and supply. You will act as a key Quality interface between Pharmanovia and its external partners, overseeing quality systems, deviations, investigations, CAPAs, change controls, complaints, out-of-specification (OOS) results, supplier qualification and audit programmes. You will also support technology transfer, process validation and the transition of products from project development into routine commercial supply. The successful candidate will bring substantial pharmaceutical quality experience, strong technical knowledge of biological products, sound risk-based judgement and the ability to influence stakeholders across an international organisation. You will be comfortable working independently, challenging external partners where necessary and maintaining Quality independence while building effective professional relationships. This is an opportunity to contribute directly to product quality, supply reliability and patient safety within a growing international speciality pharmaceutical business.

Main Duties & Responsibilities

• Write, review and negotiate Quality Agreements to ensure key responsibilities are documented and ensure completion of assigned Quality Technical Agreements in line with Project timelines
• Plan and execute external audits, and ensure schedules and audit KPIs are updated.
• Provide effective quality oversight of the Quality aspects of several Contract Manufacturing Organisations during project phase and transition to business-as-usual
• Quality oversight of CMO Deviations, Change Controls, and complaints
• Support timely discussion of OOS results with other Quality/Technical staff
• Leading reviews and investigations in a timely manner and timely escalations to Manager/QP as required
• Liaise with internal and external stakeholders as required to achieve timely completion of all CAPAs relating to Customer & Internal Audit CAPAs
• Ensure oversight of stability programmes and storage conditions for biological products, including protocol approval, trend review, temperature excursions and cold-chain requirements.
• Timely completion of ad hoc and other tasks as assigned
• Provide Quality support for technology transfer and process validation of biological drug substance and drug product, including assessment of critical quality attributes, critical process parameters and comparability requirements.
• Identify, review, and present any quality risks associated with the product, and escalate them to the project manager and Line Manager.
• Provide Quality oversight of biological products and biosimilars, including mammalian cell culture or microbial manufacture, purification, aseptic processing, biological drug substance and drug product manufacture, analytical testing, comparability, stability, cold-chain controls and contamination-control risks.
• Assess and escalate biological product quality risks, including process variability, adventitious-agent and viral safety, bioburden and endotoxin control, critical material attributes, process changes and product comparability.
• Develop effective professional relationships with CMOs/CDMOs and affiliate companies while maintaining appropriate Quality independence.

Qualifications

• Bachelor’s degree in pharmaceutical sciences or equivalent; postgraduate degree or diploma is a bonus
• Good working knowledge of current GMP, SOPs, EU GMDP requirements and ICH guidance applicable to biological products, including EU GMP Annexes 1 and 2 and relevant ICH Q5 guidance.
• Experience in the manufacture, testing, and Quality oversight of biological products or biosimilars is required, preferably covering monoclonal antibodies; biological drug substance and drug product; aseptic processing; and cold-chain distribution; experience with oral dosage forms is advantageous.
• Working knowledge of biological product regulations and guidance, including EU GMP Annex 1 and Annex 2, ICH Q5 principles, process validation, comparability, viral safety, contamination control and data integrity.
• Experience of routinely preparing and negotiating Quality Technical Agreements
• Experience of facilitating OOS and Root Cause Analysis
• Excellent professional communication skills, both written and verbal
• Precise and attentive to detail when reviewing critical due diligence documents and escalating product quality issues to the Manager.
• Excellent IT skills across all MS packages, including Excel, Word, PowerPoint, Outlook, and Teams
• Ability to work on own as well as part of team
• Ability to build strong professional relationships
• Collaborative across the CFT

Pay range and compensation package

We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.

Equal Opportunity Statement

Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. Pharmanovia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.