Director, GVP Compliance Job at BioMarin Pharmaceutical (London)

Associate Director, Integrated Pharmacovigilance Operations

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Di...

Location

United States , Waltham, Massachusetts; San Diego, California

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
Demonstrated understanding of safety databases, medical literature, and electronic data capture technology
Working knowledge of validated drug safety databases and MedDRA coding dictionary
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera
Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals
Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required

Job Responsibility

Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
Assist with data reconciliation and support safety signal management and aggregate data review activities
Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions

What we offer

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

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

Senior Director, Vaccines Medical Affairs Lead

Provide scientific leadership for the vaccine business in Japan. Develop and exe...

Location

Japan , Tokyo

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD)
10+ years of Medical Affairs experience in vaccines/infectious diseases, including 7+ years of people leadership
Proven track record in national-level strategy development and execution for new product launches/indication expansions
Experience in scientific dialogue with PMDA, MHLW, municipalities, and academic societies (presentations, chairing, committee participation)
Practical understanding of Pharmaceutical Affairs Law, GCP, GPSP, GVP, Clinical Research Law, Personal Information Protection Law, JPMA Code
Deep expertise in vaccine-related Medical Affairs
Leadership: Inspire, develop, and lead teams in dynamic environments with scientific excellence
Communication and relationship-building skills across internal and external stakeholders
Compliance: Promote appropriate use through understanding of industry regulations
Learning agility: Ability to quickly self-learn necessary medical/scientific knowledge

Job Responsibility

Develop annual Medical Affairs Plans (MAPs) aligned with Japan’s infectious disease epidemiology, NIP (National Immunization Program), local implementation, and decision-making processes
Lead launch preparation and execution for new products, indications, and technologies
Identify unmet medical needs and healthcare disparities via advisory boards
create and drive action plans to address data gaps
Lead unbiased scientific communication, HCP education seminars, data generation initiatives, and development of scientific materials
Contribute to lifecycle planning for both inline and pipeline vaccines
Design Japan Evidence Plans covering epidemiology, outcomes, and implementation science
Utilize databases (JMDC/MDV/NDB) and regional cohorts to visualize effectiveness, safety, and real-world implementation
Oversee publication and conference presentation plans
Support investigator-initiated studies and medical grants per internal policy

Fulltime

Associate Director, GCP Quality – R&D QA

Are you passionate about providing pragmatic, risk-based quality leadership that...

Location

Denmark , Søborg

Salary:

Not provided

Life Science Talent

Expiration Date

March 23, 2026

Requirements

Solid experience in clinical trial management and/or QA/compliance within clinical development. Typically, 10+ years of industry experience within clinical development and preferably at least 2+ years in QA/Compliance roles.
Strong, in-depth knowledge of GCP
familiarity with GvP and/or GLP is an advantage
Proven experience conducting audits, supplier qualification, and supporting regulatory inspections
Hands-on experience managing deviations, CAPAs, and change control in a regulated environment
Demonstrated ability to apply risk based thinking to deliver compliant, pragmatic solutions
Strong communication and stakeholder management skills, with the ability to influence and lead without formal authority

Job Responsibility

Lead quality oversight for specific clinical development projects or defined components, ensuring alignment with GCP and internal QMS requirements
Provide expert, risk-based QA guidance to clinical trial teams, particularly during trial startup and execution of critical milestones
Serve as a key resource and mentor for QA Managers within your area of expertise
Drive and support GCP training for Development organization
Plan, conduct, and oversee audits (e.g., GCP, GvP, GLP) and ensure timely, effective follow-up of audit findings
Support and contribute to inspection readiness activities and regulatory inspections, including preparation, hosting support, and responses
Lead or support assessment and management of suspected serious breaches related to clinical trials, including escalation and documentation
Drive cooperation with our preferred service providers QA functions according to established Clinical Quality Agreements.
Oversee and drive quality events such as deviations, CAPAs, and change controls, applying sound judgment to resolve complex issues
Lead continuous improvement initiatives within the development QMS, incorporating industry trends and regulatory expectations

Fulltime

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New

Associate Director, Customer Experience UFS

The Associate Director of Customer Experience is a senior leader responsible for...

Location

United States , Hoboken

Salary:

146200.00 - 219400.00 USD / Year

Unilever

Expiration Date

Until further notice

Requirements

9–10 years of experience in Customer Operations (Supply Chain), Customer Development (Sales), related roles, with a strong track record in direct customer engagement
Experience partnering with senior leaders and cross-functional teams to deliver outcomes
Skilled in storytelling, customer collaboration and strategic thinking
Strong relationship management and team leadership both internally and externally

Job Responsibility

Act as a thought leader, co-creating UFS engagement strategies with Sales, Marketing, and functional partners that anticipate UFS customer needs and drive commercial priorities
Challenge norms and introduce innovative approaches to elevate UFS presence across every touchpoint
Own end-to-end design and delivery of customer engagements, HQ visits, industry forums, and high-profile UFS events ensuring seamless, premium experiences
Craft compelling narratives that position Unilever as the benchmark for partnership excellence
Develop and maintain strong key relationships with top UFS distributors
Work with cross-functional colleagues to drive customer excellence in meeting service targets as measured by the customer (SAMBC)
Develop standardized reporting that understands gaps with customers and evaluate trade-offs to satisfy both Unilever and UFS customers
Implement continuous improvement opportunities that drive value for Unilever and UFS customers
Act as a connector across functions, ensuring alignment and consistency in how Unilever engages customers, and shows up at internal and external events
Influence leaders at all level to ensure everyone is on the same journey and be able to create an impact with UFS customers

What we offer

health insurance (including prescription drug, dental, and vision coverage)
retirement savings benefits
life insurance and disability benefits
parental leave
sick leave
paid vacation and holidays
access to numerous voluntary benefits
bonus eligible
Long-Term Incentive (LTI) eligible

Fulltime

New

Revenue Operations Manager - Upmarket

The Revenue Operations Manager – Upmarket owns operational execution, forecast i...

Location

United States , Austin, Tempe

Salary:

Not provided

Dialpad

Expiration Date

Until further notice

Requirements

7–10 years of total professional experience
4–6+ years in Sales Operations, Revenue Operations, or GTM Strategy
Experience supporting Direct Sales Teams and/or Channel organizations
SaaS experience strongly preferred
Strong analytical mindset with the ability to turn data into decisions
Comfortable working with ambiguity and building structure where none exists
Excellent executive communication — written, verbal, and storytelling
Ability to influence senior stakeholders without formal authority
High ownership mentality: you see problems and fix them
Detail-oriented but able to zoom out to the bigger picture

Job Responsibility

Define and enforce opportunity stage entry and exit criteria
Establish deal inspection frameworks by segment and deal size
Identify and eliminate poorly qualified pipeline, stalled or aging deals, inflated close dates and optimistic forecasts
Create clear standards for when deals advance, reset, or exit the pipeline
Own forecast methodology and call discipline across segments
Standardize forecast categories (Commit, Best Case, Pipeline, etc.)
Lead or co-lead weekly forecast calls with Sales leadership
Track and surface forecast bias, slippage patterns, and risk signals
Improve forecast accuracy, confidence, and consistency over time
Design and run pipeline councils by segment

Fulltime

New

Academy Administrator

Learning Curve Group are a national training and education specialist we work wi...

Location

United Kingdom , Exeter

Salary:

24570.00 GBP / Year

Learning Curve Group

Expiration Date

March 31, 2026

Requirements

Previous experience within an administration function
Excellent Communication at all levels both face to face and remote
Excellent IT Skills
Ability to work unsupervised and work well as part of a team
Excellent organisational skills
Good time management

Job Responsibility

To be responsible for the running of reception/front office and greet visitors
To provide administration support to academy manager and delivery staff within the academy
Monitor exams bookings for all sectors, booking exams, preparing invigilation packs, seating plan, and exam laptops for each weekly session
Monitor all workshop bookings dealing with queries, booking workshop sessions, and maintaining the centre planner with any updates
Advise commercial customers of the eligibility requirements for initial and reassessment courses checking with tutors for accuracy and currency of their qualifications
Registers learners with awarding organisations (AO’s), and claim certificates as requested by Lead Tutors and IQA’s
Arrange and track inductions of new starts
Liaise with stakeholders and learners to book employability courses, complete sign-up documentation, book CSCS tests, and coordinate CSCS cards as required
To be responsible for Data input of student data onto MIS system and update as required
Set up E Portfolio accounts for commercial learners and archive accounts once completed

What we offer

26 days annual leave + Bank Holidays
Buy & Sell an additional 5 days each year
Length of service annual leave increments starting at 2 years
Healthcare Scheme
Home & Tech schemes
Enhanced Family Leave
Paid Volunteer day each year
Early Finish Fridays on the last Friday of every month
Student / Teacher Discount
Uniform

Fulltime

New

Resort Maintenance Technician

Resort Maintenance Technicians perform routine and preventative maintenance to m...

Location

United States , Jacksonville

Salary:

15.00 USD / Hour

Sun Communities

Expiration Date

Until further notice

Requirements

High School Diploma or GED
6 months in previous maintenance experience in a campground or RV resort (Preferred)
Demonstrated knowledge of and broad experience in general maintenance techniques and repair work
Ability to endure seasonal temperatures as working conditions require constant outdoor work
General knowledge of janitorial work, plumbing, and grounds maintenance
Proficient skills in operating various hand tools, power equipment, and commercial machinery
Ability to provide legible written reports
Ability to work well independently as well as on a team
Must be able to lift at least 50 pounds
Basic computer proficiency, including the ability to use email and internet

Job Responsibility

Empty trash, shovel, perform maintenance or repair duties, use power equipment, drills or other hand tools
Completes minor repairs to rental units and facilities as needed
Completes routine maintenance and minor emergency repairs, plumbing, sewage, construction & street repair
Inspects irrigation system regularly to ensure it is working properly, repairs as necessary
Inspects playground area and equipment, pool/spa area, and other recreational amenities to ensure everything is in good condition, making minor repairs as needed
Ensures the resort is presentable and inviting at all times and that it adheres to Sun's curb appeal standards
Regularly treats for weeds, weed whips, rakes leaves, plants flowers/shrubs, spreads mulch/woodchips/stones, trims shrubs and hedges, cuts down and removes tree limbs damaged by adverse weather conditions, and performs other lawn care services as necessary
Ensures trash/debris is picked up daily from common areas and streets on a daily basis. Empties common area trash containers as needed
Cleans resort amenities which may include clubhouses, tennis courts, pickle ball courts, resort offices, restrooms, laundry areas, bath houses, and maintenance garage
Maintains vacant sites, including strap-downs & removal of trash and debris

What we offer

Get paid daily with DailyPay
401(k) Plan with employer matching contribution
Employee Assistance Program
Identity Theft Insurance
Team Member Perks & Discounts program with hundreds of discounts on things like travel, merchandise, mobile phone service, and more
Discounts at Sun Outdoors locations across the nation
Paid sick leave
Various paid holidays, bereavement time and pay for jury duty

Parttime

Director, GVP Compliance

BioMarin Pharmaceutical

Location:
United Kingdom , London

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 09, 2026

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