Senior Director, Quality Assurance GCP Job at Life Science Talent (Boston)

Senior Director, R&D GxP Audit

The Senior Director, R&D GxP Audit will lead the global strategy, execution, and...

Location

United States

Salary:

199782.30 - 270293.70 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master's degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor's degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities
Lead internal, external, and supplier audit programs across R&D and supporting functions
Serve as a strategic advisor to the Head of R&D Quality on compliance trends, systemic risks, and assurance strategies
Build and lead a high-performing audit organization with strong technical and leadership capability
Oversee audits of clinical trial processes, pharmacovigilance systems, laboratories, quality systems, and supporting functions
Ensure audits assess both compliance to regulations and effectiveness of quality management systems
Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally
Evaluate third-party quality systems, regulatory history, data integrity controls, and operational capability
Support qualification, ongoing oversight, escalation, and remediation of critical suppliers
Use quality risk management principles and data analytics to prioritize audits based on business criticality, compliance history, inspection outcomes, and emerging risks

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

R&D Clinical - Quality Compliance Senior Manager

We are hiring a R&D Clinical Quality Compliance Senior Manager, who will operate...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s Degree in appropriate discipline e.g. Life Sciences, Medical
15-18 years’ experience working in Biotech, Pharmaceutical or CRO company
In-depth knowledge of ICH GCP
Extensive experience in Quality Management, Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are core responsibilities
Experience using electronic QMS such as Veeva Vault and eTMF
Experience and understanding of Clinical R&D activities and Global Regulations
In-depth knowledge of the Regulatory Submission and Inspection readiness, preparation and management procedures
Extensive experience in Quality Oversight of Clinical Trials, including clinical trial protocol development and execution
Strong verbal and written communication skills, including strong business writing abilities and active listening
Strong analytical, critical-thinking, and decision-making abilities

Job Responsibility

Key advisor to the study team throughout the clinical trial life cycle, providing independent and objective quality input in the areas of GCP and compliance with Amgen SOPs and processes
Review and provide input into the development of the initial clinical study protocol and subsequent amendments, with focus on quality by design, confirming it’s fit for purpose, clear, concise and consistent
Actively provide input into study risk assessment activities
Review and provide input into other key study documents and plans
Direct study teams through the management of complex quality issues
Participate in key activities related to Risk Based Quality Management
Using available tools, analyze quality data metrics
Monthly meetings with study team lead/associate director, to review the following: on-going quality issues, quality trends, program filing timelines, inspection readiness, potential inspections and audit scheduling and planning and any other topics deemed relevant
Support the clinical study team with inspection readiness activities
Support continuous improvement initiatives within TA Quality

What we offer

Varied opportunities to learn, develop, and move up and across our global organization
Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act
Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth, and career benefits
Flexible work arrangements

Fulltime

Director, Clinical and Safety Quality

The Clinical & Safety Quality Director is responsible for establishing, leading,...

Location

United Kingdom , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 10–12 years of experience in pharmaceutical or biotech environments
At least 5 years in Clinical Quality Assurance and/or Pharmacovigilance Quality roles
Direct experience supporting Phase II–IV clinical development programs
Hands-on experience with regulatory inspections and health authority interactions
Experience in global or multi regional clinical development organizations is strongly preferred
Strong expertise in ICH-GCP and GVP requirements applicable to Sponsors
Demonstrated experience in clinical and/or pharmacovigilance quality oversight in a pharmaceutical company environment
Solid knowledge of outsourced clinical development models and CRO/vendor oversight
Proven ability to lead inspections, audits, and complex quality issue resolution
Strategic mindset with the ability to balance compliance, risk management, and operational agility

Job Responsibility

Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations)
Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners
Lead the development, maintenance, and continuous improvement of Clinical and PV Quality Management Systems, including SOPs, standards, and governance processes
Plan and execute quality oversight activities, including: Clinical and PV audits (internal, vendor, affiliates, system, and study audits), Quality risk assessments, Vendor qualification and performance monitoring
Ensure inspection readiness and act as quality lead during regulatory inspections (EMA, FDA, MHRA, PMDA) related to clinical and safety activities
Oversee CAPA management, deviation handling, and root cause analysis related to clinical and safety quality issues
Provide quality input and decision support to clinical development teams, pharmacovigilance, regulatory affairs, and senior management
Promote a quality culture across clinical and safety organizations, supporting training, coaching, and awareness initiatives
Monitor regulatory intelligence and proactively adapt quality processes to evolving requirements (e.g. EU CTR, ICH E6(R3), digital trials)
Contribute to portfolio and program governance committees as quality subject matter expert

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Director of Planning

Amgen is one of the world’s leading biotechnology companies, driven by a mission...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Supply Chain Management, Engineering, Life Sciences, or Business Administration
advanced degree preferred
20+ years of progressive experience in supply chain and planning roles within pharmaceutical, consumer packaged goods (CPG), or fast-moving consumer goods (FMCG) industries
Deep understanding of GMP and GCP interfaces, regulatory requirements, and the unique complexities of managing investigational products
Proven success leading large-scale, cross-functional planning organizations in a global matrix structure
Strong digital acumen – experience implementing or operating advanced planning systems such as SAP IBP, Kinaxis Rapid Response, OMP, or equivalent
Expertise in end-to-end planning, network optimization, and business performance management
Exceptional analytical, strategic thinking, and communication skills with a proven ability to influence senior executives

Job Responsibility

Lead the integrated global planning function encompassing both global clinical and commercial supply chains, ensuring synchronization between demand, supply, and inventory management
Drive operational excellence and agility through robust planning processes and advanced digital planning tools
Provide strategic leadership on planning priorities, ensuring alignment with global supply chain strategies and patient delivery commitments
Oversee global demand consolidation and insights to ensure a robust consensus forecast focused on reducing demand variability and providing a quality input into the commercial planning and scenario modeling processes
Collaborate with regional planning teams to address demand trend breaks or provide insights to support a robust demand review process with country affiliates, partners and distributors
Lead the clinical supply planning function, ensuring investigational materials are available on time, in full, and in alignment with clinical development timelines and regulatory milestones
Lead commercial supply planning to secure uninterrupted product supply, optimizing network efficiency, cost, and service levels
Collaborate closely with manufacturing, quality, regulatory, and commercial teams to balance global priorities and local execution
Lead development of sophisticated supply network models to assess capacity, lead time, and risk scenarios
Drive digital and data-led decision-making to evaluate alternative network designs and risk mitigation strategies

Global Study Director - Hematology/Oncology - Cell Therapy

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

United States; Canada , Montreal; Cary; Burlington; Blue Bell; Philadelphia; Pittsburgh

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
Proven project management experience and training
At least 7 years of clinical trial experience
At least 3 years of experience in global study leadership and team leadership
Demonstrated clinical trial expertise in Hematology - Oncology
Extensive knowledge of ICH-GCP guidelines and clinical research regulatory requirements and experience in all phases of clinical study delivery
startup, maintenance and close out
Thorough understanding of the cross-functional clinical trial process eg. Data flow
Strong strategic and critical thinking abilities
Proven skillset and abilities in complex problem solving and decision-making

Job Responsibility

Lead and coordinate a cross-functional study team of experts in accordance with SDO/STOM and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards
Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection
Assist the (Sr)GPD with the operational planning for upcoming clinical studies to establish required number of resources for study conduct, interfacing with other cross-functional partners and the TA as required
Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended)
Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan
For outsourced studies, be the primary point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)
Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant
Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities
Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team
Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

New

Marketing Consultant

The Marketing Consultant will be responsible for supporting new and existing sch...

Location

United States

Salary:

Not provided

Goldfish Swim School

Expiration Date

Until further notice

Requirements

BA in Marketing, Public Relations, Communications, or related field
Minimum 3+ years marketing experience
franchise and/or field marketing experience highly preferred
Willing to travel up to 15% of the time
Embrace and be guided by the Core Values of the company

Job Responsibility

Onboard new locations in assigned territory
following tiered support protocols for checklists, calls, and site visits
Oversee ongoing training, brand standards compliance, and effective use of marketing tools (programs, promotions, offers, partnerships) necessary to capitalize on local marketing opportunities
Monitor and analyze KPIs/benchmark data for opportunities for business improvement through marketing
Collaborate with internal departments to resolve questions, mediate concerns, and support the school’s overall success
Onboard, train, and monitor all franchisee social media channels in designated territory
auditing post frequency and ensuring brand standards while helping to drive engagement
Oversee and assist with partnerships, including third-party local marketing/PR companies, to ensure their understanding of processes and programs and use of brand-approved materials
Develop and maintain strong franchise, franchisee, and vendor partner relationships and ensure expectations are being consistently met
Assist with team projects as needed

What we offer

Health insurance
Paid time off
Vision insurance
401(k)
401(k) matching
Dental insurance
Flexible work from home options available

Fulltime

New

Front Desk and Sales Associate

We're looking for a friendly, driven, and detail-oriented Front Desk and Sales A...

Location

United States , Flushing

Salary:

18.00 - 22.00 USD / Hour

Goldfish Swim School

Expiration Date

Until further notice

Requirements

Mandarin or Spanish-speaking ability preferred to support our Mandarin and Spanish-speaking customer base
A natural communicator who is comfortable on the phone and in person with families of all backgrounds
Comfortable learning new software - we'll train you on our systems
Organized, dependable, and proactive about following through on tasks and commitments
Previous customer service or administrative experience preferred
Basic computer skills
Required to obtain CPR, First Aid, and AED certifications through Goldfish Swim School
Must be available for evening and weekend shifts

Job Responsibility

Greet every member and family warmly at check-in and make them feel welcomed from the moment they walk through the door
Answer phones, respond to inquiries, and conduct outbound sales calls to prospective members with a positive, confident approach
Guide families through the student registration process using effective sales and customer service techniques
Handle customer concerns and complaints professionally, with a solution driven approach
Assist families with merchandise and vending purchases
Make calls to resolve open account issues with professionalism and care
Maintain a clean, organized, and well-stocked front desk, snack area, changing rooms, restrooms, and lobby area
Enforce safety rules and administer first aid when necessary

What we offer

Paid Training
Flexible Schedules
All Are Welcome
Make Waves...In Your Community
Make Waves...In Your Career
High Fives & Tropical Vibes
Going for Gold
Grow with Goldfish

Parttime

New

Accounts Receivable Specialist

We have an immediate need for an Accounts Receivable Specialist for our client i...

Location

United States , Modesto

Salary:

Not provided

Robert Half

Expiration Date

Until further notice

Requirements

Experience with ERP, accounting, or receivables systems preferred
Knowledge of accounts receivable processes, credit review, account reconciliation, collections, and multi-entity or multi-location accounting environments preferred
Ability to manage recurring deadlines, prioritize collections activity, follow up consistently, and escalate issues appropriately
Strong problem-solving, research, documentation, and organizational skills
Solid understanding of basic accounting principles
Strong data entry and multitasking abilities with a high level of accuracy
Self-starter with a professional attitude and dependable work style
Proficiency in Microsoft Excel and Word
strong numeric/data entry skills preferred
Strong organizational and time management skills

Job Responsibility

Process customer credit applications from start to finish
Set up and maintain customer accounts in internal accounting and operational systems
Monitor accounts receivable activity, aging balances, payment status, and collection priorities
Contact customers regarding past-due balances, follow up on payment commitments, and document collection activity
Research and resolve billing, cash application, credit, rebill, short-pay, and reconciliation issues
Prepare credit memos, refunds, write-offs, monthly statements, deposits, and daily cash posting
Prepare and distribute recurring aging reports and account updates
Support industry-related receivables requirements
Assist with month-end accounts receivable and cash receipts responsibilities
Provide backup support to other team members

What we offer

Medical
Vision
Dental
Life and disability insurance
401(k) plan

Fulltime

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Senior Director, Quality Assurance GCP

Job Description

Job Responsibility

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