QUALITY & REGULATORY COMPLIANCE (QRC) SUPPLY CHAIN SPECIALIST Job

Job description

QUALITY & REGULATORY COMPLIANCE (QRC) SUPPLY CHAIN SPECIALIST-1500058724WDescriptionQuality & Regulatory Compliance (QRC) Supply Chain Specialist UK & IrelandLocation: UKEmployees of the Johnson & Johnson Family of Companies work with partners in healthcare to touch the lives of over a billion people every day, throughout the world. Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson.
Within a Johnson & Johnson company, you have the advantage of a supportive, team-oriented environment where individuals’ capabilities and potential are recognised and nurtured. We believe in offering “big company” opportunities within a “small company” feel, embracing research and science – bringing innovative ideas, products and services to advance the health and well-being of people.
Johnson & Johnson comprises around 250 operating companies, employing 128,000 people in 57 countries with over 5,000 in UK companies across 9 cities/11sites.
Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products and related services. With three distinct healthcare sectors: consumer health care; medical devices and diagnostics; and pharmaceuticals, we provide our employees with the opportunity to grow and develop diverse careers.
Are you ready to work for an organisation that cares deeply about their patients, employees and the local communities in which we operate?We have an exciting opportunity for an experienced Quality Regulatory Compliance (QRC) Specialist who will lead Johnson & Johnson Medical Devices UK Supply Chain Quality initiatives.
The Quality & Regulatory Compliance Team (QRC) is a fast developing department within J&J UK/Ireland Medical Device Marketing Companies. Separate from Regulatory Affairs, we drive the Quality Management Systems and Post Marketing Surveillance elements for the businesses working with numerous departments to ensure compliance is integrated into all levels of sales and marketing. We are looking for a new member of the team to lead our Supply Chain Projects. This position will preferably be located in our Pinewood office in Bracknell but our Leeds office or remote working arrangements will also be considered.
This role will report to the QRC Lead UK/Ireland and involve significant collaboration with colleagues in other J&J sites as well as on the ground. At times, it may require up to 50% travel. This role requires you to work successfully within a virtual team, have motivation to succeed and diverse, well rounded quality management skills.
The role also includes the following:
- Represent the QRC Team in Supply Chain projects, manage all aspects of the QMS in relation to site requirements
- Partner with internal and external Commercial Partners, explaining Compliance requirements related to supply chain processes.
- Establish a culture of compliance in the Supply Chain Dept.
- Embed QMS management principles in the organization & drive continuous improvement
- Ensure timely implementation and compliance with J&J requirements
- Monitor QRC and other compliance targets,
- Manage effectively customer feedback as part of the Post Market Surveillance process
- Maintain a comprehensive audit readiness program to ensure internal and external compliance
- Host and manage site audits from regulatory bodies, franchise and corporate audit teams.
- Assist with establishing corrective & preventive actions to mitigate potential or actual non-compliance risk
- Drive appropriate Management Review processes to ensure ongoing Management awareness of the compliance state, and escalation of issues where appropriate.
- Assist to ensure local licenses are in place (as applicable)QualificationsTo be part of this critical team you will be degree qualified coupled with relevant Supply Chain Quality experience in leadership roles and have a real desire to see projects through to completion.
Together with:
- Quality/Compliance knowledge, preferably in ISO standards 9001:2008 and 13485:2012, European & National Good Distribution Practice, Post Marketing Surveillance of Medical Devices, pharmacovigilance as well as a good understanding of Quality Management System requirements
- Capability to work across departments to implement new standards and programs (particularly experience with Supply Chain/warehousing is essential)
- Internal & Lead auditor qualifications are desirable
- Experience of hosting external auditors
- Experience of work within a virtual team
- Capability of working independently, taking responsibility for the management of projects and timelines,
- A talent for leading a strong compliance culture.
This is a great career pathway to amazing opportunities for people with a desire to make a difference to patients all over the world. If we have described your next move, then click on the APPLY button.
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Primary Location:Europe/Middle East/Africa-United Kingdom-England-WokinghamOrganization: Johnson & Johnson Medical Ltd.
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