Quality Manager in Cwmbran

Nanopharm, an Aptar Pharma Company, is a world leading specialist contract research and development organization offering product development services for orally inhaled and nasal drug products (OINDPs). Nanopharm operates a fee-for-service model, helping its clients navigate the scientific, technical and regulatory challenges in developing nasal and respiratory drug products from discovery through to clinical investigations (‘IND’).

Its service offerings provide the most efficient path to success for its clients by providing an integrated product development service covering:

• Advanced materials characterization
• Analytical method development
• Formulation development and testing
• Inhaled biopharmaceutics

These early phase services aid successful product development by understanding how material properties and processing conditions influence product functionality and therefore reduce risks and expedite drug development timelines. Nanopharm’s proprietary technology and analytical platforms for advanced materials characterization, formulation & device development and in-silico modelling of in‑vivo behaviour, have provided Nanopharm a technical competitive edge, helping it become an international market leader.

The Quality Manager is responsible for the day-to-day management and delivery of Quality Assurance operations, ensuring that GMP and non‑GMP activities are performed in compliance with regulatory requirements, company procedures, and client commitments. The role provides hands‑on QA leadership across routine quality system activities, laboratory oversight, internal and supplier audit programmes, and inspection readiness.

The post holder applies pragmatic, risk‑based quality judgement appropriate to a contract laboratory operating mixed regulated and non‑regulated activities. The Quality Manager acts as a senior quality practitioner and people manager, supporting operational teams, coaching staff in GMP and non‑GMP expectations, and deputising for the Head of Quality as required.

Day‑to‑Day QA Operations & Compliance

• Provide routine, hands‑on QA oversight of GMP and non‑GMP laboratory activities.
• Maintain effective day‑to‑day operation of the Pharmaceutical Quality System (PQS), including deviations, CAPAs, change controls, Laboratory Investigations, quality records and management of quality events.
• Ensure quality events are assessed, investigated and closed in a compliant, timely and risk‑based manner.
• Perform or support batch, data and documentation review activities where required.
• Lead, perform and report internal audits in accordance with the site audit programme.
• Plan and conduct supplier audits and supplier quality assessments, supporting supplier qualification and ongoing performance monitoring.
• Act as a key Quality representative during client audits and regulatory inspections.
• Coordinate responses to audit observations, including oversight of CAPAs and effectiveness checks.

Quality Systems, Data Integrity & Compliance

• Support maintenance and continuous improvement of the PQS, ensuring procedures are current, effective and consistently applied.
• Apply data integrity principles and CSV expectations across GxP systems and supporting tools.
• Ensure compliance with EU GMP (including Annex 11), FDA 21 CFR Parts 210/211, FDA 21 CFR Part 11, and ICH Q8, Q9 and Q10.

Leadership & People Management

• Line manage 2 QA direct reports and provide functional oversight and mentoring to up to 4 indirect reports.
• Support training, coaching and competency development across QA and operational teams.
• Provide clear, consistent and authoritative QA guidance in an approachable and collaborative manner.
• Identify and drive improvements to QA processes, systems and ways of working.
• Actively promote a strong quality culture and continuous improvement mindset across the site.

Basics

• Always promote Nanopharm & Aptar’s best interests by the positive and effective way you perform your duties modelling our Core Values and Rules of Leadership.
• Always comply and proactively engage with Environment, Health, Safety and Sustainability policies, procedures and instructions to ensure the safety of you and your colleagues.
• Always comply and proactively engage with Quality policies, procedures and instructions to ensure we deliver quality work, data and reports.
• Read and understand all assigned Standard Operating Procedures (SOPs) via the Quality Management System (QMS) in the timeframe specified.
• Maintain an up‑to‑date training record and submit to your line manager at least annually for review, making updates and amendments as necessary.
• Complete timesheets, expenses claims, objectives and appraisals in a timely manner as specified by Stakeholders and in line with the relevant company policies.
• Ensure confidential information pertaining to the company is not divulged to 3rd parties without the appropriate permission.
• Ensure use of IT equipment (e.g. phones, laptops, etc.) is in line with the appropriate Aptar policies.

EDUCATION, Experience & RELEVANT Skills

Education & Qualification

• Preferably a first degree in a science, pharmacy or relevant discipline of grade 2.1 or above.

Experience

• Significant experience working in Quality Assurance within a GMP‑regulated environment.
• Experience operating in a contract laboratory or service‑based organisation conducting GMP and non‑GMP activities.
• Demonstrable experience of conducting internal audits and supplier audits.
• Experience supporting and hosting client and regulatory inspections.
• Experience implementing or significantly enhancing electronic Quality Management Systems (eQMS).

Skills

• Strong working knowledge of EU GMP, FDA CFRs, Annex 11 and ICH Q8, Q9 and Q10.
• Sound understanding of data integrity and CSV principles.
• Proven ability to apply pragmatic, risk‑based QA decision making.
• Approachable, credible and collaborative leadership style.
• Confident communicator with internal stakeholders, clients and regulators.
• Practical, solution‑focused and calm under inspection conditions.
• Strong personal commitment to quality, compliance and continuous improvement.
• Demonstrated proactive and organised approach, able to exert influence over those whom they do not have direct authority and proven ability to prioritise and manage multiple tasks.
• Excellent customer related experience and customer facing skills, with the drive to ensure that this ethos is instilled within your team.
• Ability to communicate and work with personnel of all levels, internally and externally.
• Proven flexibility in adjusting to a rapidly evolving workload and remaining calm under pressure.
• Displays adherence to and promotion of the company values at all times.

What we offer:

• An exciting, diverse and value based working environment.
• Award‑winning corporate university offering personal development and training opportunities.
• Competitive base salary and performance‑based bonus plan.
• Innovative benefits plan, which includes: medical, life, disability and wellness.

Aptar is an equal opportunities employer. We believe that a diverse workforce is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief.