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Bachelor’s Degree within a life science focus area, master’s degree is a plus
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Head of R&D Quality
GCP Compliance Team
GLP Compliance Team
Head of Global PV Operations
Regulatory Affairs
Commercial Operations
BioMarin is a world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. To support this important mission, we are looking for an individual with experience working in Pharmacovigilance (PV) within the space of Quality and Compliance.This important role will be joining our Global Quality organization and reports into the GVP Compliance Lead.
This role advises internal and external key stakeholders on Good Pharmacovigilance Practices (GVP) matters and assesses compliance with global regulations/guidelines, corporate policies, and standard operating procedures. This individual will perform GVP audits and act as a key point of contact supporting the readiness and execution of GVP regulatory inspections and identifies and works in partnership with stakeholders to resolve regulatory compliance risks and related issues.
BioMarin is a global, high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, clear communication, effective collaboration, strategic thinking and strong decision making are important skills the candidate would possess.
Candidates must adhere to established processes and policies, demonstrating professionalism and integrity in all situations. They should ensure patient safety in pharmaceutical practices through a comprehensive strategy that integrates regulatory compliance, risk management, pharmacovigilance, and continuous improvement.
Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Technical Operations
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.
Associate Director, GVP Compliance
London, UK
Hybrid role (2 days per week onsite)
None
SHIFT DETAILS
Shift will be 8 hours per day.If EU employee identified, shifts include at least (2) days per week with required partial overlap with the US EST and PST hours of operation.
ONSITE, REMOTE, OR FLEXIBLE
This role has the flexibility to be a remote position, covering both EU and US time zones.There is no requirement to be strictly onsite, however, staff local to the SRC, Shanbally, Dublin, London and Novato offices will be expected to be onsite following the hybrid role requirements.
TRAVEL REQUIRED
May travel up to 25%+ of the time
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.
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.
Originally posted on Himalayas
Other benefits are as per company policy.
Work from home
Full time
Remote — United Kingdom
Applications for this job are handled on the company's own website.
এই চাকরির জন্য বিজ্ঞাপনদাতা ব্যক্তি/প্রতিষ্ঠান আপনার কাছ থেকে কোন অর্থ চাইলে কিংবা নিয়োগ প্রক্রিয়া চলাকালীন কোন প্রকার হয়রানিমূলক (শারীরিক/মানসিক) আচরণ করলে অতিসত্বর আমাদেরকে জানান অথবা জবটি রিপোর্ট করুন। চাকরি পাওয়ার জন্য কোন ব্যক্তি/প্রতিষ্ঠানকে অর্থ প্রদান করবেন না। চাকরিকালীন কোন প্রকার হয়রানির (শারীরিক/মানসিক) সম্ভাবনা থাকলে সেখানে জয়েন করবেন না। কোন প্রকার অর্থ লেনদেন বা নিয়োগদাতা কর্তৃক হয়রানির দায়িত্ব Chakrie বহন করবে না।
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