QC Compliance Specialist

Boehringer is a global company that has a strong purpose; positively impacting the lives of millions, the planet, our communities and of course, positively impacting the health of people and animals. We are recruiting a Quality Control Compliance Specialist to support compliance across the QC department, providing hands‑on expertise in QMS processes, documentation, data integrity, investigations and training. The role strengthens compliance capability within QC and contributes to the ongoing development and performance of QC quality systems. This position works closely with QC, QA, Production, Technical and Engineering teams, as well as internal and external auditors and regulatory bodies.

Help drive and maintain the adherence to compliance structures within Quality Control by actively supporting the investigation and writing of QMS records e.g. Deviations, CAPA, Effectiveness Check and Change Controls. Provide on the ground SME support on compliance topics to quality control areas. Identify, plan and implement process improvements to QC methods and equipment through Change Control Process/System. Provide specialist training as required to individuals and departments. Assist with writing and reviewing SOP's and other controlled documents. Collaborate with QA to support internal and external audits and provide information as required. Identifying and prioritise areas for continuous improvement.

This is a full time 13‑month fixed term contract and hybrid role based in Pirbright requiring a minimum of 3 days onsite.

TASKS & RESPONSIBILITIES

• Quality Systems & Compliance Support

SME for the OOX process and act as the LMSO role at the Pirbright site. Proficient in using GoTrack QMS system for discrepancy management (Event, Deviation, OOX, Investigations, CAPAs, Effectiveness Checks), Change Controls, supplier qualification, and change notification. Support investigations and author QMS records. Proficient in using Veeva Vault for documentation management system and act as the document coordinator for QC. Drive adherence to compliance structures within QC and provide on‑the‑ground SME support across QC operational areas. Support internal and external audits, regulatory inspections and the preparation and review of required documentation. Identify, plan and implement improvements to QC methods, processes and equipment through Change Control processes. Identify and prioritise opportunities for continuous improvement. Actively participate in daily Tier PSQDC Meetings as required. Ensure actions from Tier meetings are carried out, escalated or followed-up in line with agreed timescales.

• Data Integrity

Map QC processes and conduct data integrity gap assessments. Work alongside the data integrity specialist and team, define remediation plans / activities to address gaps. After implementation, maintain compliance with structured outlines and systems updates while continuously improving DI compliance within the QC areas. Support ongoing improvements in data integrity principles and behaviours within QC.

• Training & Documentation Management

In collaboration with functional areas (including but not limited to Supervisors and Specialists), develop or maintain curricula on the job training modules for QC related tasks. Complete departmental training plan review. Maintain on-time document handling with compliance related to control and archiving. Continuously maintain KPIs and internal metrics for the management of systems. Prepare QC KPI metrics for the monthly QMR slides. Serve as a document coordinator in Veeva Vault for the QC department. Collaborate with QA to support internal and external audits and provide requested information. Support QC operational teams with compliance‑related tasks including discrepancies, CAPAs, change controls, documentation review and approval. Work closely with Production, Technical and Engineering teams, as well as relevant external stakeholders, to support compliance initiatives.

• Regulatory & Organisational Requirements

Ensure compliance of the area with regulatory agencies including but not limited to HSE, Biosafety and GxP standards by regularly managing the on-time review and completion of QMS records (e.g. SOP’s, Deviations, CAPAs, CC) and supporting audits and inspections when necessary. Balance competing priorities, resolve complex issues and drive process improvements across QC.

REQUIREMENTS

• Education

Strong science background; degree qualification preferred or equivalent relevant experience.

• Skills, Experience & Competencies

Experience working with quality systems, ideally within biological products or a GxP‑regulated environment. Ability to work independently and autonomously drive completion of actions. Strong stakeholder management and excellent attention to detail. Ability to work accurately and be agile in a fast‑paced, demanding technical environment. Excellent organisational skills with the ability to prioritise and reprioritise tasks as required. Strong communication skills, both written and verbal. Experience in a similar role or highly regulated environment is desirable. Good proficiency with Microsoft Office applications (Word, Excel) and GMP/eQMS systems. Positive, proactive attitude and alignment with BI’s Accountability, Agility & Intrapreneurship (AAI) behaviours.

A Disclosure and Barring Service (DBS) check will be required for the successful candidate. Any offer of employment will be subject to satisfactory DBS certificate.