BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
Our Approach
These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
Role Summary
The Quality Site Head is responsible for ensuring the highest level of quality and regulatory compliance at our Shanbally site. This includes overseeing Quality Control, Quality Assurance, Quality Systems, and QA Validation.
Key Responsibilities
* Accountable for product quality, regulatory compliance, quality systems, and related processes for the site.
* Lead the Quality function team to perform batch review, testing, and release activities to certify product in compliance with specifications and procedures.
* Mange the team to ensure valid processes, equipment, and associated computerized systems.
* Partner with Site Operations to drive quality and compliance excellence through supplying quality products from the site which are compliant with regulatory requirements and meet customer needs.
* Ensure site inspection readiness and host Health Authority inspections.
* Build talent and foster colleague development, growing the leadership and capabilities within Quality across the site organization.
Requirements
To be successful in this role, you will need:
* Advanced degree in pharmaceutical science, biology, chemistry, engineering, or related science.
* At least 15 years of work experience in the pharmaceutical industry, preferably within different functions within Operations and/or Quality & Compliance.
* 10 years of supervisory experience, preferably at multiple sites.
* Evaluation and continuous improvement of site Quality Systems.
* Demonstrated knowledge and applicability of US, European, and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices, and systems.
Leadership Responsibility
You will lead a team of approximately 6 direct reports and indirectly manage a team of around 90 colleagues.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.