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QA Site Inspection Manager

BioMarin -
Cork, County Cork

Apply Now

Job details

Full-time

Qualifications

Bachelor's degree
Leadership
Communication skills
Process engineering

Full job description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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.

QA Site Inspection Manager

Hybrid - Shanbally, Ringaskiddy, Cork

Responsibilities:

Develop strategy for and lead Permanent Inspection Readiness activities onsite. Foster a culture of permanent inspection readiness. Oversee trending of key audit / inspection performance metrics. Report and escalate issues to management.

Define the BIL self-inspection program for site. Work with PIR team to implement the annual program.

Benchmark leading practices & identify opportunities to enhance PIR capabilities.

Provide guidance & direction to stakeholders on trends in recent regulatory inspections.

Liaise with local and global colleagues to share learnings to ensure consistency across the network and alignment with global processes.

Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.

Maintain the commercial site license, working closely with regulatory colleagues to address license impacting changes.

Support site Quality Systems and escalate any potential issues / trends.

Support facilitation of site quality management review and report generation.

Other duties as assigned.

Qualifications & Experience:

Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline.

Experience:

10–15+ years experience within GMP-regulated pharmaceutical or biotechnology environments

3-5 years in leadership roles, with proven ability to influence cross-functional teams and stakeholders.

Significant hands-on experience supporting regulatory inspections.

Knowledge of EU GDP Guidelines and regional regulatory requirements.

Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk

Skills:

Excellent communication and influencing skills across all organizational

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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qa site inspection manager jobs in cork, c

QA Site Inspection Manager

QA Officer (a.i.)

Incoming QA Manufacturing Inspector

QA Manufacturing Inspector - Weekend Shift

CSA Superintendent-Capital Projects

Mechanical Project Manager

Mechanical Engineer

Senior Engineer - Development Infrastructure

Principal Engineer- Development Infrastructure

Mechanical Engineer

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