Associate Director - Quality Systems

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Associate Director - Quality Systems to join Norgine.

The person holding this position will report to the Vice President Corporate Quality and be a member of the quality team.

Main Purpose

Design, develop and maintain Quality Management Systems (QMS) that are fit for purpose across the entire Norgine business, that adapt to business needs and address all GxP regulatory requirements from R&D to commercialisation. Your mission will be to ensure compliance with regulations while fostering continuous improvement, innovation, agility, and efficiency.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

KEY RESPONSIBILITIES & ACCOUNTABILITIES

• Ensure all Quality processes needed for Norgine’s business are established, implemented and maintained up-to-date. Quality Management Systems are, but not limited to:

o Documentation Management System

o Quality Management System (including deviations, CAPAs, change controls)

o GxP Audits Management

o Inspection Management System

o Quality Risk Management

o GxP Validation Management System

o Quality metrics reporting

• Lead Quality Systems team to ensure the overall provision of a first class service to the business

• Lead the Quality Systems team to ensure SMEs are maintained and developed for all key quality management systems, presenting to auditors and regulatory inspectors as required

• Keep up to date with current and evolving regulatory requirements including changes that impact the QMS

• Identify, develop and lead the execution and continuous improvement plans.

• Ensure oversight of operational activities by developing and maintaining relevant KPIs that reflect the effectiveness of the quality management systems.

• Identify potential compliance gaps, resource constraints, adverse trending or new regulatory requirements in area of actions and formulate remediation/development proposals for endorsement by senior management.

• Ensure all staff are appropriately trained, have appropriate goals and objectives, review staff performance to identify development opportunities.

• Ensures adherence to Norgine Compliance Policies.

• Promotes Quality in compliance with the Good Practices in force and the updates of applicable regulations, particularly in :

o Ensuring accuracy or updating documentation related to its business function and in line with Norgine’s organisation,

o Proposing correctives actions, changes or improvements, and committing their implementation within timelines.

MAIN TASKS

• Lead a team to be Design, continuously develop and maintain the Quality Management System (QMS) so that processes are in place and supported to ensure compliance with regulatory requirements impacting the whole of Norgine.

• Report to senior management on the performance of the quality management system and any need for improvement, and ensuring the promotion of awareness of customer requirements throughout the organization.

• Lead and Support the implementation of compliance improvements across the Norgine business.

• Lead the continuous improvement activities to Implement and maintain the electronic QMS (TrackWise) used to manage Quality records.

• Lead and deliver the Quality related aspects of any new business systems including SharePoint and QMS .TrackWise and eQMS vendor management.

• Lead, Maintain, refine and develop the new and current business systems including the eQMS and eGSOP strategy and the potential replacements.

• Lead and support the Quality systems and Process team

• Performs and executes audits in compliance with GxP

• Ensure that company Quality related processes are harmonised and standardised to assist with compliance and improve efficiency of Norgine's Quality systems

• Host regulatory Inspections/Audits and provide responses and effective CAPA related to the QMS

RELATIONSHIPS

• lnteracts with team members across Operations, Development, and all other Business Units, and relevant committees

• Leadership and line management of staff.

• External opinion leaders to promote the Norgine view and capture best practices

• External regulators as the Norgine Subject Matter Expert

SKILLS & KNOWLEDGE

• Degree or equivalent in a scientific discipline or equivalent experience in Quality Management

• Experience at a managerial level in a pharmaceutical organisation and a thorough knowledge of GxP/FDA guidelines for the manufacture of pharmaceutical products and ISO standards for Medical Devices.

• Clear understanding of the pharmaceutical and medical device industry

• Experience of setting up and managing Quality Management Systems

• A passion for continuous improvement and experience applying techniques such as RCA root-cause analysis, CAPA, Lean, Six Sigma

• Proven GxP auditing experience

• Ability to understand quality issues in a complex a highly regulated environment.

• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.

• Demonstrated operations experience with a can do approach.

• Demonstrated ability to lead motivate and manage staff in a global multi-facility, matrix environment.

• Excellent influencing skills and ability to establish effective working relationships with personnel at all levels within the company.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.

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