Quality Manager, Clonee D15, Clonee, Dublin 15

Leinster Appointments Ltd; Dublin; On-site; EUR 85,000 - 120,000; Full time

Job summary

Leinster Appointments Ltd is seeking an experienced Quality Manager to join a growing pharmaceutical company in a newly created role. You will take ownership of the Quality Management System (QMS) and drive its development, working with internal quality and laboratory teams and external manufacturing partners.

You will ensure compliance with pharmaceutical regulatory requirements, build strong stakeholder relationships, and foster a culture of quality and continuous improvement across

Qualifications

• Strong experience within pharmaceutical Quality Assurance / Quality Management.
• Experience developing, implementing or improving a QMS.
• Experience working with manufacturing sites and/or external manufacturing partners.
• A strong understanding of pharmaceutical quality and regulatory requirements.
• Excellent communication and stakeholder-management skills.
• The confidence to operate in a newly created role and establish structure and best practice.
• A practical, hands-on approach, combined with strong attention to detail.

Responsibilities

• Taking ownership of the Quality Management System and driving its development and improvement.
• Reviewing existing quality processes, procedures and documentation and identifying opportunities for improvement.
• Acting as a key quality contact for external manufacturing partners and facilities.
• Providing quality oversight across the company’s manufacturing and pharmaceutical activities.
• Working closely with internal Quality and Laboratory teams.
• Supporting compliance with applicable pharmaceutical quality and regulatory requirements.
• Building strong relationships with internal stakeholders, manufacturing partners and other external parties.
• Driving a culture of quality, compliance and continuous improvement.

Skills

Quality Assurance

Quality Management

QMS development

Job description

We are working with a growing pharmaceutical company on the appointment of aQuality Managerto join their team in a newly created position.

Reporting directly to theCOO,this is a key role within the organisation, with significant visibility across the business and responsibility for working closely with the external manufacturing facilities used by the company to manufacture and market pharmaceutical products.

The Role

This is an excellent opportunity for an experienced quality professional to take ownership of, and help shape, the company’sQuality Management System (QMS).

The QMS is currently largely manual, and the successful candidate will play a key role in reviewing, developing and establishing a more robust and effective quality framework.

Key responsibilities will include:

• Taking ownership of the Quality Management System and driving its development and improvement.
• Reviewing existing quality processes, procedures and documentation and identifying opportunities for improvement.
• Acting as a key quality contact for external manufacturing partners and facilities.
• Providing quality oversight across the company’s manufacturing and pharmaceutical activities.
• Working closely with internal Quality and Laboratory teams.
• Supporting compliance with applicable pharmaceutical quality and regulatory requirements.
• Building strong relationships with internal stakeholders, manufacturing partners and other external parties.
• Driving a culture of quality, compliance and continuous improvement.

The company has its own 2 manufacturing operations alongside relationships with external manufacturing facilities.

The Person

We are looking for an experienced pharmaceutical quality professional who is comfortable operating with a high degree of autonomy and ownership.

You will ideally have:

• Strong experience withinpharmaceutical Quality Assurance / Quality Management.
• Experience developing, implementing or improving aQMS.
• Experience working with manufacturing sites and/or external manufacturing partners.
• A strong understanding of pharmaceutical quality and regulatory requirements.
• Excellent communication and stakeholder-management skills.
• The confidence to operate in a newly created role and establish structure and best practice.
• A practical, hands-on approach, combined with strong attention to detail.

There are currently no direct reports associated with the position, although the wider quality and laboratory function comprises approximately 26 people.

The Package

What's on Offer

This is a newly created opportunity offering the successful candidate the chance to have asignificant impact on the quality function and QMS, with considerable autonomy and exposure across the business.

Salary: Negoiable depending on experience with excellent benefits

Leinster Appointments is committed to providing a professional service where all CVs are kept confidential and will not be submitted to any third parties without candidate’s knowledge or consent.
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