The Quality Specialist – EU Operations will support the PPS EU Quality Manager in overseeing the Quality Management Systems across the EU Leiden office, as well as managing interactions with the Morpeth and India sites. The role ensures that business and compliance objectives are achieved in line with monthly sales and revenue goals.
You will work closely with the Supply Chain team to ensure that the importation of finished products into the EU is conducted through registered sites and in compliance with all applicable Good Distribution Practice (GDP) regulations and other relevant laws.
Key responsibilities include the management and maintenance of the Manufacturing/Importation Licence for Piramal Dutch BV, adherence to EU Good Manufacturing Practices (GMP), and ensuring compliant batch disposition in collaboration with EU Qualified Persons (QPs).
The position requires proactive Quality oversight, effective stakeholder coordination, and continuous improvement to maintain compliance while driving operational efficiency.
KEY RESPONSIBILITIES
* Support and ensure Quality oversight of the EU Leiden office and all associated interactions with Morpeth and India sites.
* Manage and maintain Quality and regulatory processes related to the Manufacturing/Importation Licence for Piramal Dutch BV.
* Collaborate with EU QPs to ensure compliant product disposition according to supply plans.
* Establish, track, and report on Key Performance Indicators (KPIs) for quality, safety, delivery, and cost.
* Ensure the Morpeth and India PTP QMS incorporates all EU office requirements.
* Travel to the EU office as needed to maintain effective Quality oversight and support all Piramal and customer quality needs.
* Coordinate with Morpeth and India teams to ensure timely vendor management, self-inspections, and other activities impacting the EU supply chain.
* Support all customer and regulatory audits of the PPS BV office.
* Oversee day-to-day operations between EU contract testing providers, storage/distribution depots, and Morpeth/India sites to ensure timely batch disposition.
* Provide relevant Quality metrics for business performance reporting.
* Work with QA Client Liaison Officers to ensure accurate and timely communication as per relevant Quality Technical Agreements (QTAs).
* Escalate any Quality issues to the PPS EU Manager as required.
* Support and lead continuous improvement initiatives to enhance both compliance and efficiency.
* Stay up to date with EU–UK regulatory changes and ensure these are adequately implemented within the QMS.
* Maintain current QTAs and QP-QP agreements affecting the EU office.
* Raise and manage change controls for EU operations (e.g. MIA updates).
* Act as the primary point of contact between the EU office, Morpeth, and India sites in the absence of the PPS EU Manager.
* Monitor and evaluate the performance of EU contract testing facilities using KPI reviews and regular business meetings.
* Align activities with PPS business goals, ensuring EU operations support broader sales, financial, and customer service objectives.
* Support the PPS EU Manager in responding to new customer inquiries, contributing to business growth across all Piramal facilities requiring EU-based services.
ESSENTIAL QUALIFICATIONS
* University degree preferred (or equivalent professional experience).
RELEVANT EXPERIENCE AND SKILLS
* Significant experience within the pharmaceutical industry in a Quality Assurance, Quality Control, or Regulatory role.
* Strong knowledge of GMP requirements, including MHRA Orange and Green Guides, EU EudraLex Vol. 4, US CFR 210/211, and related ISO, ICH, GAMP, and PIC/S standards.
* Ability to apply regulatory requirements using a pragmatic, risk-based approach.
* Proven experience managing regulatory processes within EU quality operations.
* Excellent communication, organizational, and problem-solving skills.
* Exceptional attention to detail with the ability to manage multiple priorities effectively.
* Strong collaboration and stakeholder management skills across international teams.
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