The Quality Assurance Manager leads and guides the NRG PALLAS organization through its roadmap to become a professional nuclear organization capable of delivering high quality pharmaceutical products to its customers. The NRG PALLAS roadmap includes the development of assets, an advanced R&D program, a product roadmap and a commercial roadmap. While the organization has an established quality organization, challenges exists on implementing its pharmaceutical quality policies by the leadership team and by the current and future operational teams.
And therefore NRG PALLAS is looking for a:
(Senior) Quality Assurance Manager (nuclear/pharma)
N2025031/PQMMain tasks
- Exemplify the right company leadership behaviors.
- Guarantee and lead full alignment with nuclear regulatory and quality related matters as managed by (Nuclear) Safety/QHSE and Security departments within NRG PALLAS.
- Provide direction and leadership to the site’s (Nuclear) Pharmaceutical Quality and Regulatory Function.
- Oversee pharmaceutical regulatory and quality related matters to ensure NRG PALLAS complies with applicable regulatory and company internal requirements and standards.
- Provide regulatory and quality oversight, management and support for research, process development and manufacturing, testing and product release of (nuclear) medicinal products.
- Be responsible and accountable for the timely regulatory filing and the quality of products released and distributed by NRG PALLAS.
Responsibilities include the following:
- Strategy: lead the development and implementation of the NRG PALLAS Quality and Regulatory strategy. Benchmark, implement best practices, ensure continuous improvement. Lead the alignment of pharmaceutical and nuclear regulatory and quality related matters.
- Team: recruit, develop and direct high quality staff to establish a flexible, motivated Quality and Regulatory team and an inclusive work environment.
- Implement: realize pharmaceutical licensing of the relevant NRG PALLAS assets and products. Provide technical and scientific support to introduce new products and services
- Lead: direct and lead the Pharmaceutical Quality and Regulatory function, including registration activities, testing, audits, stability testing (as applicable) and release activities. Ensure that released products are manufactured and tested within regulatory and company standards. Ensure a robust deviation management process exists and is consistently executed.
- Develop culture: ensure quality management systems (including training) are in place and operated in an effective and efficient manner; a culture of built-in quality, right first time quality and continuous improvement is pursued; a culture of thinking “compliance first” exists with quality & compliance ownership and accountability at all functions at all levels
- Inspect: ensure permanent inspection readiness to successfully pass inspections by (national, European, global) regulatory agencies and customers. Liaise with regulatory agencies and customers during registration activities and site inspections. Ensure that licenses are up-to-date and maintained.
- Communicate: ensure effective communication and collaboration to execute common objectives to support quality and regulatory compliance excellence, reliable compliant supply, operational efficiencies and cost, as well as the implementation of the site strategic initiatives.
Reporting lines
The Quality Assurance Manager reports to the Director Compliance, Risk & Organization, member of the Board of Directors. The Quality Assurance Manager elevates issues in a timely manner to the Director CRO. When necessary the CRO will elevate issues to other members of the Board of Directors or to the Supervisory Board.
pharma):
- Expertise and experience in Quality Systems, Quality Assurance and Quality Control in (nuclear) pharmaceutical business environment.
- Expertise in (managing) local GMP regulations and expectations.
- Expertise in (managing) interdisciplinary areas of (nuclear) science & technology, (nuclear) pharmaceutical operations, analytical chemistry, microbiology and nuclear/sterile operations,
- Excellent problem solving capabilities based on science, facts, data and understanding of the regulatory requirements in complex and evolving environments.
- Capability to apply risk management methodologies.
- Capability to influence management of complex R&D activities, manufacturing operations and supply chains, protecting company image and reputation with key internal and external stakeholders.
- Capability of interpersonal, communication, negotiation, persuasion and leadership skills in dealing with a broad variety of functions and cultures on non-routine matters in stressful situations. Capability to build strong relationships without compromising functional responsibilities.
- Capability of establishing performance metrics and holding people accountable for results.
- Leadership capabilities include: ethics & integrity, make sound decisions based on “safety first, quality always”, courage, deliver customer and stakeholder value, demonstrate respect for people, embrace diversity and inclusion, speak up and be open minded.
Skills/Knowledge Required/Preferred:
- Minimum of 10 years’ experience in the pharmaceutical industry, with solid (pharmaceutical) regulatory, quality and compliance experience. Preferably with experience in a nuclear pharmaceutical business environment.
- Minimum of 5 years management experience and a proven track record in people management skills, including providing strategic direction and leading and motivating teams.
- Preferably master’s Degree in (Nuclear) Chemistry, Pharmacy, Biology, Chemical Engineering; ideally a Qualified Person under Directive 75/319/EEC requirements.
- Solid knowledge of GMP / cGMP’s and regulatory environments. Knowledge of ISO frameworks used for certified management systems in nuclear industry.
- Expertise in regulatory affairs, quality systems, quality assurance and quality control.
- Excellent problem solving skills, based on science, facts, data and understanding of regulatory requirements in complex and evolving environments; must be able to apply sound risk management.
- Operational Excellence/LeanSixSigma knowledge and expertise.
- Excellent project management and organization skills.
- Strong demonstrated interpersonal, communication, collaborative and leadership skills in dealing with a broad variety of functions and cultural backgrounds.
- Ability to be decisive and influence management with demonstrated leadership skills to drive change in a compliance culture.
Terms of employment
Besides an interesting position and meaningful work, NRG also offers you good terms of employment.
Modern employment conditions package in line with the market;
- 27 vacation days and 12 days of flex time (you can also sell your flex time at 5.26% more gross pay);
- 8.3% year-end bonus and 8% vacation allowance;
- Pension with the ABP; NRG pays 70% of the premium;
- Commuting expenses are reimbursed at € 0.23 per k/m up to a maximum of 50 km one way;
- A travel allowance and mobility budget of € 5,000 net (paid once, if you live 1.5 hours travel distance from our work location);
- A moving allowance if you do not live in the Netherlands. This concerns an amount up to a maximum of € 2,750 which you can declare to our finance department.
Personal development
- An onboarding program for everyone new to the company;
- An annual training budget and room for your own wishes.
Flexibility and work-life balance
- Possibility to buy 2 weeks extra leave per year;
- Partially working from home is an option.
Fun activities
- An active staff association that organizes many social and sporting events every year;
- The opportunity during your lunch break to take a walk in the beautiful dune area or to use our fine company restaurant.
Information & application
Learn more about this position or our company, please contact our corporate recruiter Rogier Gervers 06- 2713 2468 or email recruitment@nrg.eu.
For more information about our company, check out our corporate company page www.nrg.eu.