QA Site Inspection Manager
QA Site Inspection Manager - Shabally, Ringaskiddy, Cork
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. 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.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
Essential Job Functions
- Develop strategy for and lead Permanent Inspection Readiness (PIR) activities onsite including external regulatory inspections, internal self-inspections and global BMRN audits.
- Foster a culture of PIR at BioMarin International Ltd (BIL) Shanbally site, across Drug Substance Manufacturing, Drug Product Filling & Finished Goods Packaging operations.
- Define & implement quality standards, systems and metrics to sustain regulatory compliance onsite.
- Define and conduct the BIL self-inspection program for site.
- Support the preparation of reports e.g. Site Master File, APR, Quarterly Reports, SQRT etc.
- Maintain the BIL commercial and clinical MA, working closely with regulatory CMC colleagues to address license impacting changes.
- Support Regulatory International in collating information for GMP Applications/Renewals/Filings as required.
- Benchmark leading practices & identify opportunities to enhance PIR capabilities.
- Provide guidance & direction to stakeholders on trends in recent regulatory inspections.
- Liaise with local & global colleagues to aid harmonization of Global Quality functions and systems
- Support site Quality Systems and escalate any potential issues / trends.
- BA/BS degree in chemical engineering/chemistry/life sciences; process engineering or validation.
- At least 8 years of experience in a relevant functional area.
- Direct experience with compliance responsibilities
- Liaison with regulatory bodies and partners in hosting internal & external GMP inspections.
- Interface with and lead cross-functional teams in a QA / Compliance context
- Experience in drug substance manufacture, fill finish & drug product packaging is a distinct advantage
- Knowledge of applicable global regulatory requirements
- Collaborate and ability to interact with all levels of the organization
- Disciplined, detail orientated and excel in personal time management
- Diplomatic and tactful with critical reasoning skills
- Strong problem solving and analytical skills
- Excellent written and verbal communications skills
- Flexibility to work both independently & supporting/working in teams in a collaborative manner
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.