QA Director of Operations

QA Director of Operations

As QA Director of Operations, you'll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you'll be reporting to the Senior Quality Director.

Your Responsibilities
Essential duties and responsibilities of this role include and are not limited to the following;

* Key member of the Quality Leadership and Site Leadership Team. Be a strong delegate for the Senior Quality Director.
* Responsible for all aspects of quality associated with the manufacturing and release of medicinal products.
* This role will lead and manage multiple key quality functions including Quality Management System, Quality Qualification & Validation, Quality Client Management, Quality Drug Substance Operations.
* They will be accountable for the oversight of activities to ensure compliance to SOPs, cGMP and CMC regulatory requirements as well as acting as a Quality advocate for the Quality Department.
* The role will require extensive liaison with counterparts, business, and quality leaders across WuXi Biologics (Local and Global reach). This will require the highest level of professional representation of the local site Quality organisation.
* Partner with Quality colleagues and other business stakeholders to provide leadership and direction on product quality investigations, critically assess and support impact assessments were needed and liaise with QP, Client and/or CMC regulatory affairs with regard to mitigations such as change controls, variations etc.
* In collaboration with the Senior Quality Director and relevant colleagues across Local and Global Quality, develop and implement the strategic objectives for the Quality organisation inclusive of headcount management, and budget design.
* Build and develop a high performing Quality management team, including attracting and maintaining a strong talent pipeline from within and beyond the WuXi network.
* This role will be accountable for Quality Organisational design, to ensure optimum structure to achieve quality compliance. This role will work closely with counterparts and peer companies to ensure best in class industry standards are achieved and aligned.
* Working with the Senior Quality Director - To ensure accurate, relevant reliability and metrics are in place as key Quality performance indicators.
* Ensure that site's quality standards, practices, procedures, and documentations are in accordance with cGMP regulations, pharmacopoeia, and corporate global, regional, & the site requirements, industry standards and best practices
* This role will support the culture of Quality on site and drive improvements in all areas of compliance and setting expectations and standards for adherence. Create a culture of audit readiness.
* Key leader in ensuring regulatory compliance and achievement of licences associated with manufacturing of bioproducts. Establish site strategy to ensure continuous compliance to regulatory and client expectations.
* Drive quality system development, establishment, and improvement for Dundalk Biologics Manufacturing site.
* Ensure the engagement of the Quality Assurance organization with Learning and Development initiatives and the performance management system for the site.
* Ensure adherence to all safety and quality standards.
* Will be flexible to take on additional tasks and responsibilities at the discretion of the Senior Quality Director.
* Act as a role model for the Quality Organisation - Speak with one quality voice and demonstrate PROUD values and behaviours.

Your Profile

The ideal candidate for this position, will have the following:

Qualifications

* Advanced degree (Bachelor, Master, or PhD) in Chemistry, Biochemistry, Microbiology, Molecular Biology, Biological Engineering, or other life science related fields.
* QP Qualified Highly Desirable.

Knowledge/Experience:

* At least 15-20 years relevant work experience in quality and leadership experiences in pharmaceutical industries.
* Demonstrated examples of deliverance and compliance success.
* Must be familiar with EMA & FDA regulations; ICH and WHO guidelines.
* Must have a proven track record of extensive knowledge and experience gained within the biopharmaceutical/pharmaceutical industry sector.
* Proven risk management - Identification and Control.

Behavioural Competencies

* Excellence in leadership, providing clear direction and focus to the Quality team and wider business functions.
* Proven ability in leading high performing teams, setting the highest professional standards.
* Ability to interact well with all levels of staff, including senior management with excellent problem-solving capabilities.
* A strong work ethic with a proven track record identifying continuous improvement opportunities within the Quality function and beyond.
* Excellent analytical and project management skills with ability to handle multiple projects at once. Excellent strategic decision-making capabilities.
* Excellent business acumen/commercial awareness.

Other Requirements:

* Must be willing to travel as required internationally to fulfil the responsibilities of the position.

Delegation of Responsibilities:
When absent from the site duties and responsibilities will be delegated to the following designates:

* Job Title: Senior Quality Director
* Job Title: QA Drug Substance Operations Lead
* Job Title: QMS Lead
* Job Title: QAV Lead

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O'Connell on +353 (0) 86 126 3871 or send your CV to doconnell@berkley-group.com