VP of Quality
Our client is a biopharmaceutical company focused on identifying, developing, acquiring and commercialising differentiated and accessible medicines through its orphan, rheumatology and primary care business units. With global sales of more than $1 billion, it has grown at a rapid pace and is recognised as one of the best places to work.
With its global headquarters in Dublin, Ireland, it now wishes to appoint a Vice President of Quality who will be responsible for the commercial operational quality approach and execution. A significant aspect of this function is the development and implementation of improved commercial quality operational systems to ensure the highest levels of compliance and productivity.
This is a business-critical role with responsibility for commercial operational oversight, communication to the broader technical operations team and supporting consistent, reliable supply of quality commercial product. It requires the effective oversight and execution of MIA licensure support, inspection readiness & support of all corporate quality efforts.
Sitting on the Technical Operations Leadership Team, key responsibilities will include:
- Partnering with CMOs / Distributors / internal Supply Chain to ensure quality of commercial product consistent supply. Compliance and safety of commercial product released to market.
- Overseeing the implementation and execution of all quality system transactions that support commercial supply and corporate quality efforts.
- Decisions which are focused on key strategic and operational matters that have significant improvement to compliance and productivity standards within the quality operations team based in Dublin.
- Setting and aligning goals & objectives for the operational quality function with overall Technical Operations & Company objectives. Ensuring that these objectives are accurately monitored, clearly communicated across the organisation and consistently delivered.
- Personnel development, quality product compliance and successful implementation of improved quality systems.
- Relationships and successful oversight of CMO’s and all partners and stakeholders.
- Developing and driving cross-site initiatives.
- Providing leadership and direction to the quality operations organisation.
- Leading the team through infrastructure and improvement projects, report status and ensure drive to successful completion.
- Mentoring and developing staff members within and across the organisation as appropriate.
- Additional responsibilities that may be asked of this position.
The Successful Candidate will have:
- 15+ years of experience in biotech and/or pharmaceutical manufacturing.
- 10+ years of experience in quality operations (QA, QC, Quality Systems) within biopharmaceutical and/or pharmaceutical industry.
- Bachelor or advanced degree or equivalent combination of education and experience.
- Highest levels of communication skills. Ability to summarise complex technical issues, written and verbal skills.
- Ability to ensure Technical Operations team, globally, is fully informed of all critical activities and projects.
- Strong strategic understanding and working knowledge of Quality Systems (FDA QSIT and ICH Q10) and how those systems are implemented to meet FDA, EMA and other major jurisdictional requirements.
- Experience supporting MIA, pharmaceutical product lines, and medical device or combo products.
- Led and hosted inspections for regulatory agencies, partners and clients.
- Experience developing, implementing and executing strategic plans and objectives for organizations and departments.
- Exceptional internal / external customer & stakeholder interface and collaborative skills experience.
- The capacity to be comfortable with continuous change and ambiguity - with the resilience and gravitas to positively challenge decisions and colleagues as appropriate.
- Ability to work hours necessary to support global network needs.
This is an exciting opportunity to join an organisation at a key stage of its development, where you will be significantly empowered to lead the team and build out the structures and processes to deliver a best in class quality function. Given the visibility of the role and the evidence that success should provide, it is also an opportunity to develop a profile in an organisation with a strong track record on promoting from within.
To apply, please email in strict confidence quoting Ref. No. 19602 giving full career details and summarising your relevance to:
130 Rathgar Road
Dublin D06 KF22
IrelandTel: +353 1 496 6500