QA Validation & Projects Manager Job at Alliance Medical Ltd (Guildford)

QA Manager, External Supply Quality

In this position, you’ll lead quality oversight for Amgen Contract Manufacturing...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of directly related experience OR Bachelor's degree and 4 years of directly related experience OR Diploma and 8 years of directly related experience in Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities
Technical experience with synthetics/small molecules a strong plus
Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)
Confident communicator who can build relationships across technical and cultural boundaries
Track record of driving change, improving systems, and mentoring/coaching others
Skilled in using risk based decision-making approaches
Experience with regulatory activities and variation management

Job Responsibility

Lead quality oversight for Amgen Contract Manufacturing locations in the JAPAC region
Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen's high expectations
Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement
Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls
Provide quality oversight and approval steps for new product introductions, tech transfers, analytical and method qualifications and validations, and process qualification activities at the contract manufacturing site
Perform tactical batch disposition activities in support of lot release
Negotiate Quality Agreement terms and conditions and ensure adherence
Perform supplier audits for key manufacturers within the JAPAC region
Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
Take the lead in cross-functional initiatives and continuous improvement projects

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Drilling & Projects Manager

The Drilling & Projects Manager is responsible for managing Fairweather’s direct...

Location

United States , Anchorage

Salary:

Not provided

Doyon

Expiration Date

Until further notice

Requirements

Bachelors degree in Engineering or equivalent on the job experience
10 years of drilling and completions experience
3 years of Alaska Experience
5 years of previous leadership experience
Must possess a valid driver's license

Job Responsibility

Identify business opportunities to provide planning, design, project management, operational oversight, and operational support services to clients in Alaska
Support business development by securing contracts for Fairweather, LLC through client engagement, Request for Proposal (RFP) responses, and preparing Work Orders
Monitor department financial health by managing department budget, forecast, revenue, and expenses
Maintain oversight of client project statuses to ensure Fairweather delivers the highest level of support at all times
Perform Quality Assurance (QA) on department work products
Manage and develop technical and operational staff to support project-based work
Collaborate with other Fairweather Business Line Managers on projects that incorporate multiple business lines
Coordinate, monitor, and provide client’s direction to service providers and subcontractors
Communicate with all parties involved in project planning and execution
Maintain Fairweather’s HSE standards, provide safety leadership, and drive a zero-incident culture

What we offer

Medical Coverage (FEHB plans)
Dental
Vision
401(k) up to 4% company match
Short-term and long-term disability
Life insurance
Voluntary supplemental coverage
Employee Assistance Program (EAP)
Paid Holidays
Flexible Spending Accounts

Fulltime

QA Projects Officer

We are seeking a QA Projects Officer to provide quality and validation support a...

Location

United Kingdom , Guildford

Salary:

Not provided

Alliance Medical Ltd

Expiration Date

Until further notice

Requirements

Degree in a scientific discipline (or equivalent experience) within a pharmaceutical or regulated manufacturing setting
Strong background in QA, validation, qualification or quality systems, ideally with 5+ years experience
Experience working within radiopharmacy, nuclear medicine, sterile manufacturing or aseptic processing environments
Demonstrable experience supporting commercial products and IMP development activities
Strong working knowledge of UK and EU GMP, MHRA requirements and GxP compliance
Experience supporting audits, inspections and regulatory authority interactions
Experience working across multi-site operations and engaging multiple stakeholders
Excellent written and verbal communication skills
Strong organisational skills with a high level of attention to detail
Ability to work proactively and independently while contributing effectively to team objectives

Job Responsibility

Providing QA and validation support across all UK Radiopharmacy facilities
Supporting inspection readiness and participating in client audits and regulatory inspections
Acting as an advisor to site teams on validation, projects and quality continuous improvement activities
Supporting commercial and IMP project activities from a QA perspective
Ensuring consistent application of GMP, GDP and MHRA requirements across sites
Supporting regulatory interactions with the MHRA and other authorities, including audit responses and ongoing compliance actions
Managing and harmonising project documentation, including deviations, CAPAs, change control and risk management
Reviewing and approving quality and regulatory documentation, including SOPs, batch documentation and validation protocols
Providing QA input into product development, technology transfer and validation activities within sterile and radiopharmacy environments
Supporting project teams in driving continuous improvement and quality culture across the UK network

Fulltime

Technical QA Manager

At Amgen Breda medicines are labelled, assembled, stored and eventually shipped ...

Location

Netherlands , Breda

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree in Engineering, Pharmaceutical Sciences, Process Technology or equivalent
Previous experience in a GMP environment, within the pharmaceutical industry
Minimum 1 year of people management experience
Demonstrated experience with equipment and automation/IS validation, computer compliance
Experience with risk management methodologies (e.g., FMEA)
Proven project management capabilities
Experience with Nonconformances, CAPAs and Change Control
Experience with statistical tools supporting sampling plans or hypothesis testing
Strong leadership and coaching mindset
Excellent communication skills across functions and levels

Job Responsibility

Manage, lead and motivate the TQA team, including hiring, coaching, capacity planning and performance management
Ensure robust QA oversight for validation of equipment, automation and information systems, guaranteeing compliance with Corporate, Site and Regulatory (GMP) requirements. Provide subject‑matter expertise in complex quality investigations and continuous improvement initiatives
Lead or support internal and external audits, acting as a key quality representative. Review and approve deviations, CAPAs, Change Controls and equipment‑related changes, ensuring quality and regulatory requirements are met
Guide validation and technical project strategies in collaboration with Process Development, Maintenance & Engineering, ATMOS and Manufacturing
Act as QA contact for technical change controls and ensure end‑to‑end compliance of all project documentation

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance
Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food

Fulltime

QA Validation, Senior Associate

Proclinical is seeking a Senior Associate, Quality Assurance Validation to provi...

Location

United States , Boston

Salary:

90.00 - 97.00 USD / Hour

Proclinical

Expiration Date

Until further notice

Requirements

A degree in Science, Logistics, or a related field is preferred
Strong knowledge of GxP regulations and ability to apply them to validation and operational activities
Hands-on experience in areas such as Quality Assurance, Quality Control, Manufacturing, Technical Support, Facilities Engineering, or Computerized Systems/Automation
Proficiency in managing change controls, deviations, and CAPA processes
Excellent cross-functional collaboration skills to drive compliant and practical outcomes
Highly organized and capable of managing multiple priorities in a team-oriented environment
Effective verbal communication skills to convey quality expectations clearly
Exceptional technical writing skills for validation and quality documentation
Adaptability and flexibility in a fast-paced, evolving environment
Continuous improvement mindset with a focus on innovation and process enhancement

Job Responsibility

Oversee the validation lifecycle, ensuring documentation accuracy, completeness, and compliance with regulations and internal procedures
Collaborate with teams across Validation Engineering, IT, Manufacturing, and other departments to develop and maintain risk-based validation strategies
Ensure validation activities align with regulatory expectations, including FDA, ICH, NIST, GAMP 5, and PIC-S guidelines
Provide quality input, review, and approval for change controls, deviations, CAPAs, and risk assessments to mitigate risks to product quality and data integrity
Promote inspection readiness through proactive issue identification and collaboration across GxP functions
Embed data integrity principles into all validation activities, systems, and documentation
Represent Quality Assurance Validation on project teams, offering strategic guidance and quality oversight
Utilize data-driven and risk-based methodologies to support effective validation outcomes
Demonstrate leadership behaviors that align with core values and foster a culture of quality and compliance

QA Manager, Commercial Production

The Manager, Quality will lead the Quality team in providing guidance and direct...

Location

United States , Madison

Salary:

109000.00 - 185000.00 USD / Year

Exact Sciences

Expiration Date

Until further notice

Requirements

Bachelor’s degree in an engineering or science field with focus on Biology and/or Chemistry, or related field with the equivalent combination of education and experience
5+ years’ experience in a biotech manufacturing environment, preferably in a GMP and/or ISO13485 environment
2+ years’ experience in a supervisory position in an Operations and/or Quality role
3+ years’ experience in Process Validation principles and practice
Proven ability to lead and work effectively with and through multi-functional teams to achieve results
Knowledge and experience working within a CFR 820, ISO 13485, ISO 9001 and/or cGMP structured environment
Authorization to work in the United States without sponsorship
Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Job Responsibility

Collaborate directly with operations and validation management in project management and status updates for ongoing activities
Provide support to Operations personnel in the completion of validation efforts for process, test method, and facility qualification/validation
Lead processes relating to supplier activities and audit programs
Provide Operations support for investigations and material release
Participate in FMEA process risk assessments
Key contributor for developing consistent strategies for Quality System requirements and improvements, and quality record workflow optimization
Implement, conduct and report on process quality programs using statistical data analysis
Participate as a Quality representative on design transfer and process improvement projects
Provide timely and transparent communication to project teams and upper management, including establishment of effective metrics for Management Review
Generate, prepare, and issue data for assigned quality reports

What we offer

Paid time off (including days for vacation, holidays, volunteering, and personal time)
Paid leave for parents and caregivers
Retirement savings plan
Wellness support
Health benefits including medical, prescription drug, dental, and vision coverage
Bonus eligibility

Fulltime

Manager QA - Drug Substance

In this vital role in support to Amgen’s Quality Assurance program, we are seeki...

Location

United States , Juncos

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Or Master’s degree and 3 years of experience in regulated industry experience
Or Bachelor’s degree and 5 years of experience in regulated industry experience
Or Associate’s degree and 10 years of experience in regulated industry experience
Or High school diploma / GED and 12 years of experience in regulated industry experience
Experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Managerial experience may run concurrently with the required technical experience

Job Responsibility

Lead the Quality team for assigned plant(s) or functional area(s), overseeing staffing, training, supervision, and performance management
Ensure products are manufactured, tested, stored, and distributed in compliance with cGMP, GDP, and applicable regulations
Maintain compliance of facilities, equipment, materials, processes, procedures, and products with cGMP and regulatory standards
Review, approve, and track cGMP documentation, including NCs, CAPAs, Change Controls, validations, and assays
Approve Master Production Records (MPs), process validation protocols and reports, Environmental Characterization reports, and planned incidents
Represent QA in New Product Introduction (NPI) teams and during audits and inspections
Lead investigations and plant audits
approve change-over completion activities
Ensure deviations are properly investigated and documented
verify accuracy and completeness of production records and test results

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
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 and an annual site shutdown
Flexible work models, including remote work arrangements, where possible

Fulltime

Accounting Compliance & Special Projects Manager

Oversee and coordinate a high volume of time‑sensitive, compliance‑driven accoun...

Location

United States , Washington

Salary:

90000.00 - 120000.00 USD / Year

Beacon Hill

Expiration Date

Until further notice

Requirements

Strong foundation in accounting operations
Solid understanding of the audit and tax process
Ability to lead staff and drive structure, clarity, and accountability
Experience building repeatable processes and maintaining rigorous documentation standards
Experience supporting cross-functional accounting initiatives

Job Responsibility

Coordinate federal, state, and local tax filings for community associations, partnering with auditors and tax preparers
Manage compliance workflows, including gathering documentation, preparing approval packages, tracking deadlines, and ensuring timely submission
Maintain regulatory portals, system access, and association registrations
Coordinate tax-related payments, property tax tracking, allocations, and true‑ups with accounting teams
Support annual budget preparation, template updates, fee validation, and QA reviews
Oversee annual audit timelines, request lists, document submissions, draft coordination, and audit adjustment entries
Assist with association onboarding/offboarding, including GL mapping, banking review, balance imports, and data transfer
Build and maintain trackers, calendars, and checklists to improve process visibility and reduce last‑minute escalations
Document processes, identify workflow bottlenecks, and recommend operational improvements
Lead and support a team of accounting staff to ensure timely execution of compliance deliverables

Fulltime

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QA Validation & Projects Manager

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