Quality Assurance Director Job at Robert Half (Bridgewater)

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Director, Quality Assurance

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part...

Location

United States , Holly Springs

Salary:

181620.35 - 245721.65 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Bachelor's degree and 10 years of Quality/Manufacturing/Engineering experience OR Master's degree and 8 years of Quality/Manufacturing/Engineering experience OR Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Bachelor's Degree in a Science field
15+ years of experience in Quality within the biopharmaceutical or regulated manufacturing industry
Previous experience in Quality oversight of Biologics drug substance operations
Strong knowledge of cGMPs and experience interacting with Regulators
Able to drive process improvement within area of responsibility
Able to successfully manage workload to timelines
Proven experience supporting regulatory inspections and site audits
Demonstrated leadership of cross-functional teams within a manufacturing site

Job Responsibility

Lead the quality team supporting drug substance manufacturing execution activities within our site's second FleX Batch manufacturing facility
Build and lead a high-performing quality organization responsible for supporting 24/7 manufacturing operations
Contribute to the development of the site Quality strategy leading teams accountable for all aspects of quality oversight of GMP systems and operations
Foster a culture of execution excellence, accountability, and continuous improvement
Provide Quality input and expertise to support project and operational design decisions
Lead operational readiness activities to implement quality systems, programs, business processes and procedures
Track progress and communicate status
Lead and participate in Quality Risk Assessments
Build organization according to hiring strategy that supports project milestones
Recruit, coach, develop, motivate, and retain staff

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives

Fulltime

Director, Quality Assurance

As a Director, Quality Assurance, you will be responsible for developing, implem...

Location

United States , Batesville

Salary:

145000.00 - 180000.00 USD / Year

Batesville Canada ULC

Expiration Date

Until further notice

Requirements

Bachelor's degree (B.A. or B.S.) with at least 10 years of progressive quality assurance experience in a manufacturing environment with at least 3-5 years in a leadership role with multi-site or regional scope
ASQ CMQ/OE certifications preferred
Demonstrated experience managing quality across distribution or logistics operations in addition to manufacturing
Strong business acumen
ability to translate quality data into business impact and executive-level narratives
Proven track record of leading cross-functional initiatives and influencing outcomes across Sales, Manufacturing, and Supply Chain without direct authority
Demonstrated experience managing external customer relationships
Deep knowledge of quality management systems and relevant standards (ISO 9000 (or similar))
Excellent problem solving, leadership, influencing and partnering skills and experience
Ability to multi-task and prioritize protecting the integrity of the Quality System, meet production needs and meet company objectives

Job Responsibility

Define and advance the Supply Chain Quality vision
Provide strategic and tactical quality oversight for all manufacturing facilities and logistics centers, ensuring product integrity from production through final delivery
Foster a culture of quality ownership at all levels — from front-line operators to site leadership — by modeling accountability and developing the team competencies in traditional tools for Quality System Monitoring, Analysis and Improvement like (Cause Effect Diagrams, SPC, FMEA, Poka Yoke, A3, Coaching, Audits, Control Plans, VSM, MSAs, DOEs, 3Ps, etc.)
Lead the development of standardized quality policies, procedures, work instructions, and documentation frameworks deployed consistently across all sites
Serve as the senior quality point of contact for strategic and high-priority external customers
build trusted, long-term relationships that position quality as a competitive differentiator
Establish and monitor quality KPIs across sites
analyze trends, identify systemic gaps, and lead targeted improvement initiatives
Conduct regular site visits and quality reviews
assess site-level team capabilities and provide coaching, development, and escalation support

What we offer

Comprehensive medical, dental and vision insurance, as well as prescription coverage, short-term disability, Employee Assistance Program (EAP), and more
Generous 401K Matching Program
Paid time off
Opportunities for development and advancement

Fulltime

Associate Director Quality Assurance

Responsible for providing oversight and leadership for Quality on-the-floor and ...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
Direct experience with bulk manufacturing of biopharmaceuticals preferred
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Job Responsibility

Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
Ensure required Quality resources are available to support commercial operations
Inspection Readiness and Support
Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
Support site/network driven QA continuous improvement initiatives/activities
Escalate significant quality issues to Quality Management in a timely manner
Act as delegate to Quality Assurance Director when required to support business needs
Support Drug Substance Alignment Meetings for Functional areas
Providing guidance to the team

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

Senior Director, Quality Assurance GCP

The Senior Director, Quality Assurance GCP is a key role within Hemab's Quality ...

Location

United States , Boston

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences, pharmacy, or a related field
Minimum 10 years of experience in GCP quality assurance within the pharmaceutical or biotechnology industry, with at least 3–5 years in a senior or leadership role
Demonstrated experience planning and conducting GCP audits across a range of audit types (CRO, site, vendor, systems)
Strong knowledge of ICH E6(R2/R3), EU Clinical Trial Regulation (536/2014), FDA GCP regulations, and related guidance documents
Experience working in an outsourced or virtual operating model, with a solid understanding of sponsor oversight responsibilities
Proven ability to manage regulatory inspections and lead inspection readiness programmes
Experience authoring and approving GCP SOPs and quality documentation
Excellent interpersonal and communication skills, with the ability to influence and partner across functions and with external stakeholders
Self-driven, pragmatic, and comfortable operating in a lean, fast-paced environment

Job Responsibility

Audit Planning and Execution
Quality Events Management
Support to Clinical Trial Teams
Inspection Readiness
Quality Working Group Participation
SOP Authorship and Approval
Building a Fit-for-Purpose Quality Organization

Fulltime

Director, Quality Assurance

This role leads the Quality Assurance function for a medical device company spec...

Location

Canada , Mississauga

Salary:

150000.00 - 200000.00 CAD / Year

Profound Medical

Expiration Date

Until further notice

Requirements

A minimum of a bachelor’s degree in engineering (Mechanical, Electrical, Biomedical, Systems, or related field)
Quality Assurance certification (ASQ CQE, CQA, CMQ/OE) is an asset
10+ years of experience in Quality Assurance within the medical device industry
5+ years of leadership experience in a regulated manufacturing environment
Deep expertise in ISO 13485, ISO 14971, and medical device quality system practices
Strong engineering background with hands-on experience in: Design transfer
Process validation
Manufacturing quality controls
DMR/DHR management
Root cause analysis and problem-solving methodologies

Job Responsibility

Lead the development, implementation, maintenance, and continuous improvement of the regulatory compliant QMS
Serve as the Management Representative, reporting to senior management on QMS performance and improvement opportunities
Ensure effective document control, training, internal audits, CAPA, nonconformance management, supplier quality, and change control processes
Partner closely with R&D to ensure design controls are rigorously applied throughout the product lifecycle
Lead risk management activities (ISO 14971, DFMEA, PFMEA) and ensure risk files remain current and comprehensive
Ensure verification, validation, and usability engineering activities meet quality and safety requirements
Lead design transfer from R&D to manufacturing, ensuring readiness of processes, documentation, and controls
Conduct manufacturability assessments and collaborate with engineering to optimize product design for production efficiency and reliability
Oversee process validation (IQ/OQ/PQ) for manufacturing processes, test methods, and equipment
Ensure effective deployment and maintenance of the Device Master Record (DMR) and Device History Record (DHR)

What we offer

group RRSP
medical benefits paid by the employer

Fulltime

Food & Safety Quality Assurance Director

Our client, a rapidly growing and dynamic leader in the beef processing industry...

Location

United States , Madill

Salary:

150000.00 - 175000.00 USD / Year

BrainWorks

Expiration Date

Until further notice

Requirements

Demonstrated leadership in Quality Assurance within a USDA-regulated, SQF- or BRC-certified meat or protein processing operation
Deep expertise in food safety management systems, including HACCP development and execution, FSMA/PCQI certification, and third-party audit management
Strong beef processing experience is a non-negotiable requirement
Proven ability to drive QA strategy at a program level while remaining engaged in day-to-day execution
Strong coaching and mentoring skills
a team builder who invests in staff development and accountability
Excellent cross-functional collaboration skills
able to influence without authority and build credibility across departments
Highly organized and detail-oriented, with the ability to manage complex documentation
PCQI certification required (or ability to certify promptly upon hire)

Job Responsibility

Design, implement, and continuously improve comprehensive food safety and quality assurance management systems
Ensure ongoing compliance with USDA regulations, BRC certification requirements, HACCP plans, and all applicable food safety standards
Serve as the facility’s PCQI and primary point of contact for regulatory agencies and third-party auditors
Lead internal and third-party audit preparation, execution, and response (BRC, customer, regulatory inspections)
Develop, maintain, and train staff on food safety programs, SOPs, GMPs, and sanitation standards
Collaborate cross-functionally with Production, QC, and Operations to embed quality standards into day-to-day workflows
Coach and develop the QA team (12-14 people), establishing clear performance expectations and fostering accountability
Manage supplier approval and verification programs, including incoming raw material and ingredient review
Track, analyze, and report on key QA metrics
identify systemic risks and lead root cause analysis and corrective action initiatives

What we offer

Bonus
Relocation assistance provided based on candidate needs

Fulltime

Director Quality Assurance

Amgen is hiring a Director, Quality Assurance in Amgen Singapore Manufacturing. ...

Location

Singapore , Tuas

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree in Chemistry, Chemical Engineering Science or related technological field and 4 years of directly related experience
Master’s degree in Chemistry, Chemical Engineering Science or related technological field and 8 years of directly related experience
Bachelor’s degree in Chemistry, Chemical Engineering Science or related technological field and/or 10 years of directly related experience
Preferred 12+ years of relevant work experience in the commercial manufacturing environment within the pharmaceutical industry
Experience with leading teams conducting batch record review, raw material and product release
Experience in pharmaceutical equipment operation, design and control
Experience in leading teams providing floor support, troubleshooting unit operations, and resolving and documenting investigations to support cGMP production
Experience in leadership roles with facility commissioning and validation strategy development and execution
Strong communication skills (technical writing and verbal communication/presentation)
Work in and lead teams effectively with variety of communication and working styles

Job Responsibility

Provide Quality leadership and oversight to plant operations, ensuring appropriate application and execution of GMP compliance requirements and Amgen Quality Management System through phases of facility design, commissioning, process qualification, regulatory approval and market supply to establish a Quality culture for routine operations
Oversee Quality Assurance support for all ASM manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval), IS, PD, F&E, QC, Validation and Supply Chain GMP activities (including on-the-floor quality oversight, Incoming Quality, Data Integrity Assessments, Periodic Reviews, PLC, Delta V, Enterprise Systems)
Supervise in New Product Introduction (NPI) team to ensure robustness of product changeover as well as cross contamination controls are in place
Oversee site inspection management, participate in regulatory inspections and interact directly with regulatory inspectors
Act as delegate to Quality Assurance Executive Director when required to support business needs

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

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Quality Assurance Director

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