Quality Director Job at SRG (Skipton)

Quality Director

As the Quality Director Duncan you will collaborate closely with cross-functiona...

Location

United States of America , Duncan

Salary:

Not provided

Danaher Corporation

Expiration Date

Until further notice

Requirements

Hold a Bachelor’s degree, preferably in Science, Business, or Engineering
Have at least 7 years of experience in Quality Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA/EPA-regulated manufacturing environments
Possess 5+ years of leadership experience, with senior leadership roles in QA, Operations, or Quality Engineering preferred
Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including operational controls, CAPA, complaints, audits, and risk management
Proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools to drive data-driven decisions and resource optimization
Proven ability to lead, coach, and mentor teams
manage performance
plan succession
and effectively communicate at all organizational levels, both written and verbal
Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities

Job Responsibility

Serve as the Duncan site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals
Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems
Support site operations and customer expectations
Drive continuous improvement with DBS mindset and in line with the global standards and customer expectations
Collaborate with site and global leadership to advocate for site-specific needs, drive customer-centric solutions, support change management and change control initiatives
Build a high-performing quality department, fostering a safe, transparent and empowering environment that encourages skill development, psychological safety, and continuous improvement
Drive efficiency in site specific quality processes
Lead Quality Management Reviews for the site, define and monitor KPIs in line with the global guidelines, host audits, and represent the site in executive discussions and global best practice initiatives

What we offer

health care program
paid time off

Fulltime

Quality Director

Global leader in the industrial sector, specializing in the development and manu...

Location

Portugal , Figueira da Foz

Salary:

Not provided

Egor

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Engineering, Quality, or a related field
10 years of experience in a similar position
Proficiency in English
Strong Knowledge of quality tools, standards, and office programs

Job Responsibility

Develop and implement a comprehensive quality strategy aligned with the company’s business objectives and customer expectations
Establish, maintain, and implement the Quality Management System in line with applicable standards (e.g., ISO)
Drive a culture of continuous improvement and quality excellence across the organization
Ensure effective quality control processes are in place across incoming materials, in-process production, and finished goods
Define and monitor quality KPIs to ensure compliance with internal and external requirements
Lead root cause analysis and corrective/preventive actions for quality issues and non-conformities
Oversee supplier quality performance, including audits, evaluations, and corrective actions
Collaborate with Purchasing and Supply Chain to ensure supplier quality standards are met
Act as the main point of contact for customer quality issues, complaints, and audits
Plan and conduct internal audits to ensure compliance with quality standards and procedures

What we offer

Opportunity to join a solid company with potential for growth and remuneration commensurate with demonstrated experience

Director / Senior Director, Quality Control Automation & Digitalization

We are seeking a Director / Senior Director, Quality Control Automation and Digi...

Location

United States , Cambridge

Salary:

210000.00 - 320000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (PhD preferred) with 15+ years of relevant experience in Quality Control, laboratory automation, and pharmaceutical or biotechnology operations, including 8+ years in progressively responsible leadership roles with demonstrated advancement to Director‑level scope
Extensive hands‑on automation experience, including 8+ years working with liquid handling platforms (e.g., Hamilton, Tecan), with demonstrated expertise in script development, validation, troubleshooting, and lifecycle management within GMP environments
Proven expertise integrating automated workflows with LIMS and other enterprise digital systems to support compliant data management and end‑to‑end process automation
Deep technical understanding of molecular biology, cellular, and immunoassay techniques, including transfection/transduction workflows, ddPCR/qPCR, flow cytometry, ELISA, and next‑generation sequencing (NGS)
Strong track record leading cross‑functional automation initiatives in regulated biopharmaceutical settings, including oversight of instrument and software IQ/OQ/PQ, analytical method qualification and validation, and method lifecycle management
Demonstrated success in building, leading, and developing high‑performing technical teams, with a proven ability to mentor, coach, and retain top talent
Exceptional communication and influence skills, with the ability to engage senior leadership and align diverse stakeholder groups around complex technical and operational initiatives
Strategic mindset with the ability to translate business and portfolio needs into scalable automation strategies, roadmaps, and executable plans

Job Responsibility

Serve as the QC Automation Lead, providing deep technical expertise and strong compliance acumen to design, deploy, and sustain automation and digital solutions supporting GMP analytical methods and procedures
Partner strategically with cross‑functional stakeholders—including Analytical Development, Automation, Computational Biology, Quality Control, Quality Assurance, Information Technology, and Validation—to define and implement integrated, end‑to‑end automation workflows
Oversee the full lifecycle of automated solutions, including instrumentation and software onboarding, qualification, and validation
robust script development and testing
and technical transfer, qualification, and validation of automated analytical methods. This includes complex modalities such as cell‑based functional assays, flow cytometry, ddPCR, ELISA, and NGS
Drive alignment on deliverables and exit criteria across Research, Development, and Commercial phases, including pre-qualification package signoffs, SME training completion, and qualification package approvals
Direct and facilitate investigation and resolution of complex technical challenges related to automated systems, ensuring scientific rigor, data integrity, and compliance with GMP expectations
Design and implement comprehensive training programs to build QC capability and confidence in automated and digital platforms, ensuring strong scientific and technical understanding across the organization
Mentor and develop team members in the design, authoring, execution, and lifecycle management of automated analytical protocols within GMP environments
Establish and maintain technical standards, best practices, and governance for automation scripting, validation documentation, system lifecycle management, and troubleshooting methodologies

Fulltime

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

Senior Director, Quality Assurance

Theradaptive is revolutionizing the field of therapeutic delivery with a pipelin...

Location

United States , Frederick

Salary:

Not provided

Theradaptive

Expiration Date

Until further notice

Requirements

Bachelor's degree (required) in Life Sciences, Biomedical Engineering, Chemistry, Biochemistry, or a related field
Advanced degree (M.S., Ph.D., or M.D.) strongly preferred
15+ years of progressive quality experience in the biopharmaceutical, biotech, or medtech industry, with at least 5 years in a senior leadership role (Director level or above)
Demonstrated experience with combination products, including working knowledge of both drug/biologic and device QMS frameworks
Direct experience managing FDA inspections (PAI, cGMP, QSR) and responding to 483 observations and Warning Letters
Hands-on experience with protein biologics or growth factors (e.g., rhPDGF, BMP, FGF, EGF, VEGF) in a GMP manufacturing or quality context
Experience with sterile or aseptic combination products is highly preferred
Expert-level knowledge of: 21 CFR Parts 210/211 (Drug cGMP), 21 CFR Part 820 / ISO 13485 (Device QMS), 21 CFR Part 4 (Combination Products)
Expert-level knowledge of: ICH Q7, Q8, Q9, Q10, Q11 guidelines
Expert-level knowledge of: ISO 14971 (Risk Management), ISO 10993 (Biocompatibility)

Job Responsibility

Design, implement, and own an integrated QMS that satisfies 21 CFR Parts 210/211 (drug/biologic GMP), 21 CFR Part 820 / ISO 13485:2016 (medical device QMS), and ICH guidelines (Q7, Q8, Q9, Q10)
Ensure the QMS addresses the regulatory designation of the combination product (PMOA-based lead center: CDRH or CDER) and the requirements of the non-lead center
Develop and maintain all quality policies, SOPs, work instructions, and quality plans across the product lifecycle
Drive QMS digital transformation initiatives, including electronic quality management platforms (e.g., Veeva Vault QMS, MasterControl, TrackWise)
Serve as the company's subject-matter expert on 21 CFR Part 3 (combination product designation), 21 CFR Part 4 (regulation of combination products), and applicable guidance documents
Lead cross-functional efforts to align quality requirements for both the protein growth factor drug/biologic constituent and the device constituent part throughout CMC development, scale-up, and commercialization
Oversee the integration of device design controls (21 CFR 820.30) with drug development quality requirements, ensuring alignment in risk management activities per ISO 14971
Collaborate closely with Regulatory Affairs on BLA, PMA, 510(k), or De Novo submission strategies — specifically quality module content (Module 3 / CTD, Design History File, Device Master Record)
Prepare and lead quality-related FDA interactions including pre-submission meetings, Agency responses, and inspection readiness activities
Support compliance with EU MDR 2017/745, IVDR, and country-specific registration requirements for international expansion

Director Quality & Patient Safety Officer

As a Director of Quality and Patient Safety at Penrose Hospital, now part of Com...

Location

United States , Colorado Springs

Salary:

55.61 - 96.63 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelor Degree required
5 years' experience in a clinical healthcare environment with a focus on quality and safety
Two years leadership experience
Experience in clinical operations, performance improvement regulatory compliance, patient safety (including HRO concepts), and data analysis
Excellent communication, problem-solving, statistical and analytical abilities
Strong PC skills and knowledge
Strong presentation and facilitation skills
Certified Professional in Health Care Quality OR Certified Professional in Patient Safety - required at time of hire or within 6 months

Job Responsibility

Functions as the entity specific or medical group Patient Safety Officer (PSO) – and is available to serve as the entity expert on quality or patient safety related issues. Has knowledge of resources to access to assist when needed
Oversees and coordinates all intradepartmental and interdepartmental services of Quality and Patient Safety
Develops, facilitates, and manages the entity specific or medical group annual QAPI plan, and maintains a quality reporting structure in accordance with the QAPI plan, regulatory requirements, and operating or medical group processes
Integrates and aligns quality work and processes which may include corporate and/or enterprise efforts
Collaborates and supports the process of developing, approving, and aligning policies and procedures for the entity and enterprise
Develops a mechanism for the internal communication of patient safety and quality information
Provides direction, coaching and support for all supervised associates to maintain their assigned job responsibilities

What we offer

Medical, prescription drug, dental, vision plans
Life insurance
Paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
Tuition reimbursement
Retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings
$10,000 sign-on bonus for qualified external applicants
Up to $10,000 in relocation assistance

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 and Patient Safety

The Boston Children’s Pediatric Physicians’ Organization (PPOC), a primary care ...

Location

United States , Wellesley

Salary:

158017.60 - 252834.40 USD / Year

Boston Children's Hospital

Expiration Date

Until further notice

Requirements

Master’s degree in Healthcare Administration, Business, or a related field
10+ years of leadership experience in quality management, quality improvement, and patient safety, including 5+ years in program or departmental leadership roles
CPHQ and Lean/Six Sigma certification preferred
prior IHI Fellowship participation is highly desirable
Demonstrated success leading quality improvement and patient safety initiatives
Strong knowledge of physician practice operations, preferably in pediatric, primary care, or ambulatory settings
Experience developing quality strategy, safety culture programs, or enterprise measurement frameworks
Experience using data and analytics to drive performance improvement
Proven ability to influence without direct authority and build relationships with physician and executive leaders
Expertise in Lean, Six Sigma, High Reliability Organization principles, and other quality methodologies

Job Responsibility

Lead PPOC’s quality and patient safety strategy in partnership with the Chief Medical Officer and senior leadership
Develop and oversee systems, infrastructure, and processes to measure, analyze, and report clinical and operational performance
Translate data into actionable insights that improve quality, safety, patient experience, and contract performance
Design and lead metric-driven improvement programs aligned with organizational goals
Advance evidence-based practices that improve outcomes, reduce variation, and mitigate risk
Partner with physician leaders, practice managers, and cross-functional teams to implement best practices
Lead strategic initiatives with defined goals, timelines, and measurable outcomes
Promote quality and safety science, continuous improvement, and high-reliability principles
Foster a culture of safety through leadership engagement, coaching, and change management
Develop tools, training, and resources to support practice-based improvement efforts

What we offer

flexible schedules
affordable health, vision and dental insurance
child care and student loan subsidies
generous levels of time off
403(b) Retirement Savings plan
Pension
Tuition and certain License and Certification Reimbursement
cell phone plan discounts
discounted rates on T-passes

Fulltime

Select Country

Quality Director

Job Description

Job Responsibility

Requirements

Looking for more opportunities?

Quality Director

Quality Director

Quality Director

Director / Senior Director, Quality Control Automation & Digitalization

Associate Director / Director, Clinical Quality Assurance

Senior Director, Quality Assurance

Director Quality & Patient Safety Officer

Director, Quality Assurance

Director, Quality and Patient Safety

Our AI answers in your language