Gvp compliance lead Job at BioMarin Pharmaceutical

Director, GVP Compliance

BioMarin is looking for a GVP Compliance Lead to advise internal and external ke...

Location

United Kingdom , London

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

Fulltime

Senior Process Quality Excellence Specialist

We are supporting a global pharma company who are seeking an experienced Senior ...

Location

United Kingdom , Slough

Salary:

40.00 - 47.00 GBP / Hour

SRG

Expiration Date

Until further notice

Requirements

8+ years' experience in the pharmaceutical industry, ideally within global Quality Assurance or Clinical Development
Strong expertise in GCP and GVP, with hands‑on experience in global audits and/or inspections
Minimum 2 years' experience writing or revising SOPs
Demonstrated ability to interpret regulatory guidance and coordinate SME engagement across functions
Excellent communication and stakeholder‑management skills, with experience supporting audits, inspection readiness, and CAPA follow‑up

Job Responsibility

Support the creation, revision, and implementation of GCSO quality and compliance policies, SOPs, and processes
Collaborate with Global Quality, Patient Safety, Regulatory Affairs, and external partners to ensure compliance with ICH GCP, GLP, PV and global/local regulations
Lead and drive inspection readiness activities across GCSO, serving as a central coordinator with inspection teams
Represent GCSO during internal and external audits/inspections, supporting preparation and follow‑up activities
Act as Regulatory Intelligence (RIN) Coordinator, reviewing regulations, identifying relevant SMEs, and ensuring CROs assess country‑specific regulatory impacts

Fulltime

Associate Director, Pharmacovigilance Planning and Innovations

Reporting to the Senior Vice President, Patient Safety and Pharmacovigilance, th...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in biotech, pharma or CRO with a demonstrated focus on pharmacovigilance, drug safety, or related field
3+ years of project or program management experience in a regulated environment
Demonstrated project management skills with strong analytical and problem-solving capabilities
Exceptional communication, stakeholder engagement, and change management skills
Strong interpersonal, organizational, and strategic planning skills
Experience working with outsourced vendors or Contract Research Organizations (CROs)
Experience leading or supporting process improvement
Adaptable to changing priorities and across multiple clinical trials and deliverables
Adept at communicating departmental vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate objectives
Proficient computer skills, including Word, PowerPoint, Excel, Visio, Power BI or similar

Job Responsibility

Coordinate and lead departmental planning activities for the PSPV organization including, e.g., headcount modeling, organizational design, and pharmacovigilance projects
Lead end-to-end project management for PV initiatives, including system implementations, process improvements, compliance programs, and organizational change efforts
Develop and maintain project plans, metrics, and dashboards to support PSPV strategies
Support resource forecasting, alliance management, and vendor oversight
Facilitate cross functional meetings, track actions, and ensure on-time execution of project deliverables
Communicate project updates to internal and external stakeholders through clear status reports, presentations, and dashboards
Ensure project outcomes align with PV strategy and broader corporate objectives
Build strong working relationships with cross functional leaders to support a proactive and collaborative safety culture
Manage and coordinate cross functional alignment for operational effectiveness and PV system/process evolution
Develop and maintain the pharmacovigilance innovation roadmap aligned with cross functional initiatives and compliance requirements

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Clinical Quality Assurance

Playing a critical hands-on role within Kailera, the Associate Director, Clinica...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in FDA regulated industry
Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
A strong customer focus and ability to prioritize and adapt to business needs are required
Strong business partner with a focus on collaborating and delivering results
Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
Understanding and knowledge of applicable industry regulations
Ability to interact constructively and efficiently within and across functional areas and management
Ability to resolve day-to-day issues efficiently while maintaining compliance
Clear, concise writing skills and good verbal communication and presentation skills
Comply with Company quality standards/SOPs and implementation of new quality systems

Job Responsibility

In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies
Monitor and track quality metrics to identify trends and areas of improvement
Ensure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness
Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program
Plan, coordinate, review and approve internal, external, and clinical site audits using risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations
Assess audit findings and develop corrective and preventative actions (CAPA)
Lead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA
Ensure that investigations are conducted in a timely and thorough manner, following established procedures
Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections
Provide guidance and support to cross-functional teams during Health Authority inspections

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Associate Director, Clinical Quality Assurance

Playing a critical hands-on role within Kailera, the Associate Director, Clinica...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

10+ years of experience in FDA regulated industry
Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
A strong customer focus and ability to prioritize and adapt to business needs are required
Strong business partner with a focus on collaborating and delivering results
Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
Understanding and knowledge of applicable industry regulations
Ability to interact constructively and efficiently within and across functional areas and management
Ability to resolve day-to-day issues efficiently while maintaining compliance
Clear, concise writing skills and good verbal communication and presentation skills
Comply with Company quality standards/SOPs and implementation of new quality systems

Job Responsibility

In collaboration with internal stakeholders, ensure risk-based quality management is applied as appropriate to specific studies
Monitor and track quality metrics to identify trends and areas of improvement
Ensure the timely completion of quality assurance activities, including audits, investigations, and inspection readiness
Facilitate review of potential Serious Breach and Urgent Safety Measure assessments arising from clinical program
Plan, coordinate, review and approve internal, external, and clinical site audits using risk-informed strategy to ensure GCP/GVP compliance in clinical studies and pharmacovigilance operations
Assess audit findings and develop corrective and preventative actions (CAPA)
Lead investigations into quality issues and deviations, identifying root causes and implementing appropriate CAPA
Ensure that investigations are conducted in a timely and thorough manner, following established procedures
Develop and implement inspection readiness plans and procedures, ensuring that clinical studies and related activities are ready for Health Authority inspections
Provide guidance and support to cross-functional teams during Health Authority inspections

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

New

Safety Intern

Join Lhoist North America’s dynamic internship program and gain hands-on experie...

Location

United States , Calera

Salary:

Not provided

Lhoist

Expiration Date

Until further notice

Requirements

Strong analytical skills
Open to feedback and eager to learn
Proactive and positive approach to work
Effective communication skills, both oral and written
High learning agility
English is mandatory
Willingness to travel if necessary

Job Responsibility

Tackle Real Projects: Dive into projects outlined by management and be ready to adapt to new challenges
Learn and Grow: Seek out work and learning opportunities proactively
Communicate Like a Pro: Engage with various levels of the organization and keep your manager/mentor updated on your progress
Improve Processes: Work efficiently and effectively to help improve processes at your location
Embrace Our Culture: Live our values of Respect, Integrity, and Courage. Work safely, especially around heavy equipment, and be a valued team member
Showcase Your Work: Present your project overview to Senior Leaders and local management at the end of the program
Stay Curious: Be eager to learn new skills and participate in all intern program activities (orientation, mid-term session, closing session, etc.)
Get There: Ensure you can transport yourself to and from the work location
And More: Take on other duties as assigned

What we offer

Comprehensive medical, dental, vision, life, and disability insurance
Paid vacation and sick time
Attractive 401(k) Retirement Savings Plan with a generous Employer Match
Supplemental Contribution based on your Years of Service
Educational assistance

Fulltime

New

Healthcare Assistant

Help us to deliver great primary care by improving access, outcomes and patient ...

Location

United Kingdom , Nottingham

Salary:

26000.00 - 30000.00 GBP / Year

Operose Health

Expiration Date

February 20, 2026

Requirements

Experience in a Primary Care setting and phlebotomy is essential
Able to work within processes, procedures and maintain confidently and data security
Must be able to adapt with changing priorities and be personable, polite and patient with our patients
Must have basic PC skills such as Word, Excel and email
Ability to use own judgement and be aware of professional boundaries they are working to

Job Responsibility

Assisting with patient duties as required and support other team members such as clinical and Nurse Lead with patient care
Supporting the Practice with duties related to CQC outcomes and ensuring compliance is maintained
Working with patients with long term conditions such as Diabetes etc
Provide clinical procedures such as new patient health checks, BMI, blood pressure, pulse and simple wound care
Completing administrative tasks such as new patient registrations, providing appropriate leaflets, stock control and ordering

What we offer

27 days annual leave plus bank holidays pro rata
Access to our bespoke learning management system and annual formative clinical assessments to support competency development
The benefits of working with an at scale provider of primary care means that we lots of opportunities for our colleagues to specialise and develop
Car benefit scheme – specialising in electric vehicles
Cycle to work scheme
Travel season ticket loans
Discount cards
Employee wellbeing services including free yoga videos and employee wellbeing app

Parttime

Gvp compliance lead

BioMarin Pharmaceutical

Location:
United States

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 26, 2025

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Gvp compliance lead

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Location:United States

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Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:December 26, 2025

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Job Posted:
December 26, 2025