Quality Director Job at SRG (Skipton)

Deputy Director of Quality Assurance and Quality Control

This position provides a high level of responsible, complex management and polic...

Location

United States , Honolulu

Salary:

120900.00 - 193490.00 USD / Year

Honolulu

Expiration Date

Until further notice

Requirements

A combination of education and experience substantially equivalent to graduation from an accredited college or university with major work in quality management, business administration, engineering, or a related field
five years of progressive experience in quality assurance, quality control, or related administrative or analytical field
experience must include active involvement in developing, implementing, improving QA/QC processes or programs, with demonstrated ability to analyze operations and develop effective solutions
a minimum of two years experience in a governmental agency or regulated industry, including experience supervising or managing QA/QC activities or teams
candidate must meet the health and physical condition standards necessary and proper for performing the essential duties

Job Responsibility

Assist, establish, implement, and maintain an effective Quality Management Plan for HART, including methods to investigate, monitor, regulate, and enforce quality standards
establish coordination of functions and operations across departments through the development and clear definition of quality assurance procedures
ensure HART’s compliance with applicable laws, regulations, rules, and generally accepted industry practices
provide additional oversight for the planning, analysis, inspection, design, testing, and/or integration of products and/or components to ensure compliance with HART’s quality assurance program
contribute to the development of contractor and quality specifications for design, procurement, and construction contracts
oversee internal and external audit, surveillance, and monitoring programs, ensuring compliance with HART's requirements
holds the delegated responsibility for ensuring that internal and external audits are scheduled, performed, and followed up
review HART’s activities, including contract work performed
help to identify and evaluate quality issues or work deficiencies, and initiate, recommend, or implement solutions and procedural changes as needed
guide and direct other quality assurance functions, including the conduct of quality engineering reviews of design plans, specifications, procedures, contracts, and request for proposals, for completeness and quality requirements

What we offer

Medical, prescription drug, vision, dental, and life insurance plans
generous vacation and sick leave, earning up to 21 days per year
13 paid holidays annually (14 days during election year)
retirement plan contributions through the Employees' Retirement System (ERS)
deferred compensation options to invest pre-tax income for retirement
flexible spending accounts for health and dependent care expenses
pre-tax transportation benefits, including TheBus and vanpool options
access to confidential counseling services through the Employee Assistance Program (EAP)
additional perks include training opportunities and employer-funded Holo Card for eligible employees to use on public transit
eligibility for Public Service Loan Forgiveness (PSLF) program, supporting employees dedicated to public service

Fulltime

Audit Director, Quality & Compliance

The Audit Director is responsible for leading the strategy, execution, and conti...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment
Demonstrated experience leading internal and external GxP audits
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP)
Experience supervising or mentoring employees
Strong analytical, organizational, and communication skills
Ability to manage competing priorities in a fast-paced, rapidly growing company
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred
Experience preparing for and supporting regulatory inspections preferred
Certifications such as ASQ, RQAP-GCP/GMP, RAC, CQA, or equivalent preferred

Job Responsibility

Develop and maintain the annual risk-based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains
Plan, schedule, and execute internal audits, vendor audits, and for-cause audits
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing
Evaluate organizational risk and adjust audit scope and approach accordingly
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards
Support team succession planning and capability building as the audit function grows
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT)
Oversee vendor and third-party audits to qualify and maintain GxP suppliers
Ensure timely issuance of audit reports, management responses, and CAPA plans

What we offer

health and retirement, PTO, and stock option plans

Senior Director Quality Assurance

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

Location

United States , West Greenwich

Salary:

218358.00 - 252850.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Quality/Manufacturing/Engineering experience
Master’s degree and 8 years of Quality/Manufacturing/Engineering experience
Bachelor’s degree and 10 years of Quality/Manufacturing/Engineering experience
At least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources

Job Responsibility

Lead Plant QA team providing Quality Oversight of 24/7 continuous manufacturing operation and high impact strategic decision making in two (2) multi-product Drug Substance facilities
Scope includes on-the-floor support for AR5 Fed batch and AR30 MoF, I-530, Buffer Preparation Area, Media Preparation, Component Preparation Area, In Process Testing Lab, record review, quality oversight of deviation investigations and changes, document approval, and disposition
Ensure drug substance is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and other applicable regulations and specifications
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Provide quality input and partner with cross-site and cross-functional area leads to advance Amgen’s manufacturing strategy
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent ARI Quality in cross-function and cross-site forums

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
Stock-based long-term incentives
Award-winning time-off plans

Fulltime

Senior Director, Quality Control Analytical Sciences

We are seeking a Senior Director, Quality Control (QC) Analytical Sciences, to l...

Location

Salary:

245000.00 - 260000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

PhD in relevant discipline (e.g., analytical biochemistry or relevant field)
15+ years of QC experience with complex biologics, particularly monoclonal antibodies, spanning late-stage development and commercialization
Proven people leader with a growth mindset, willing to learn from others, and dedication to promoting a psychologically safe environment
Excellent communicator with an ability to present to and be understood by a variety of stakeholders and tailor message accordingly
Experience with regulatory filing preparation and messaging across global jurisdictions
Deep knowledge and understanding of relevant global regulatory guidance and requirements
Ability to keep pace with a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Ability and willingness to travel up to 30%

Job Responsibility

Lead QC Analytical Sciences team, responsible for QC activities for all pipeline programs including strategies for phase-appropriate method qualification, validation, and transfer for drug substance, drug product, and drug-device combination testing
in-process/release/stability testing
specification justification and maintenance
shelf-life management
and critical documentation
Partner with new and existing external QC testing labs and CDMOs, managing relationships and all relevant activities in collaboration with TechOps Program Management, Quality Assurance, and Manufacturing
Develop analytical regulatory strategies and prepare relevant Module 3 regulatory documents
Contribute to a mature QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner
Monitor data trends, troubleshoot QC method performance, and investigate OOT/OOS results

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Deputy Director - Quality (Medical Coding)

We are seeking an experienced Medical Coding leader to join our team in Chennai ...

Location

India , Chennai

Salary:

Not provided

Access Healthcare LLC

Expiration Date

Until further notice

Requirements

Deep understanding of medical coding standards and audit processes
Experience with automation and AI solutions in coding audits
Proficiency in developing and managing quality metrics dashboards
Strategic leadership and ability to influence cross-functional teams
Strong problem-solving and decision-making capabilities
Excellent communication and stakeholder management skills
Minimum 13 years of experience in Healthcare Revenue Cycle Management (RCM) and Quality Assurance
At least 5 to 6 years of core multispecialty coding expertise
Certified Six Sigma Black Belt/Master Black Belt from recognized institutions (e.g., ISI, ASQ, Benchmark, KPMG) with proven project experience
Expertise in coding audit frameworks, accuracy improvement strategies, and regulatory compliance

Job Responsibility

Oversee comprehensive quality audits for coding across in-house teams and multiple vendors
Enforce coding best practices to mitigate risks such as missed diagnoses, over-coding, or under-coding
Drive external and internal audit programs aimed at improving compliance and accuracy
Design and elevate quality control frameworks to ensure coding accuracy and operational efficiency
Lead initiatives to reduce error rates, enhance coding precision, and boost productivity
Implement cutting-edge, AI-enabled audit solutions such as automated coding reviews and real-time QA tools
Monitor and report on Accuracy KPIs, including Missed Error Rate, Extra Error Rate, and Inter-Rater Reliability
Utilize robust data analytics to assess trends in coding accuracy and identify compliance risks
Develop executive dashboards and reports to provide insights into quality performance metrics
Partner with Operations and Training teams to address and resolve coding discrepancies while implementing corrective action plans

Director of Quality

As the Director of Quality, you will be responsible for leading operational qual...

Location

United States , Union City

Salary:

216481.00 - 237601.00 USD / Year

BillionToOne

Expiration Date

Until further notice

Requirements

8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams
Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements)
Proven track record of successfully reducing quality issues through systematic improvement initiatives
Hands-on experience with supplier quality management, including qualification, auditing, and corrective action management
Experience implementing or optimizing quality processes in a regulated laboratory setting
Strong analytical skills with ability to analyze quality data, identify trends, and develop data-driven solutions
Demonstrated ability to work cross-functionally and influence without direct authority
Ability to work independently and cross-functionally to provide effective updates at executive level
Detail-oriented with well-developed organizational and problem-solving skills
Proven ability to communicate effectively both in writing and verbally with staff at all levels

Job Responsibility

Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance
Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency
Partner directly with Lab Operations, Supply Chain, R&D, and other stakeholders to solve problems and embed quality into daily workflows
Serve as subject matter expert for operational quality matters
personally lead critical investigations and improvement projects as needed
Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions
Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making
Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency
Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables
Ensuring laboratory quality systems operate effectively to support daily operations

What we offer

Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
Open, transparent culture that includes weekly Town Hall meetings
The ability to indirectly or directly change the lives of hundreds of thousands patients
Multiple medical benefit options
employee premiums paid 100% of select plans, dependents covered up to 80%
Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
Supplemental fertility benefits coverage
Retirement savings program including a 4% Company match
Increase paid time off with increased tenure
Latest and greatest hardware (laptop, lab equipment, facilities)

Fulltime

Director of Quality Engineering

HMH is a learning technology company committed to delivering connected solutions...

Location

India , Pune

Salary:

Not provided

EdTech Jobs

Expiration Date

Until further notice

Requirements

15+ years of experience in software quality engineering
At least 7+ years in leadership roles overseeing QA/QE or Platform Engineering
Proven experience managing large engineering teams across geographies, preferably 50+ team members
Demonstrated success leading AI/automation initiatives within engineering or quality organizations
Deep expertise in modern testing strategies, CI/CD pipelines, cloud-native architectures, and tooling
Strong understanding of SDLC, release governance, and large-scale program execution
Excellent communication, stakeholder management, and leadership presence
Ability to operate in a fast-paced, matrixed global environment

Job Responsibility

Provide on-the-ground leadership for all QE teams in Pune, ensuring strong engagement, alignment, and execution
Develop and execute a strategy to elevate engineering maturity, strengthen delivery discipline, and scale operational excellence
Serve as a key member of the global engineering leadership team, driving alignment across geographies and business units
Engage with cross-functional teams, including product managers and business leaders, to align technical efforts with company objectives
Lead adoption and integration of AI, autonomous testing solutions, and agentic workflows to improve efficiency, accuracy, and delivery velocity
Champion innovation in automation frameworks, intelligent observability, and predictive analytics across QE
Evaluate and drive implementation of advanced tooling and platforms to enhance productivity
Oversee roadmap delivery for Platform and Curriculum initiatives, ensuring commitments are met with speed, reliability, and quality
Establish strong governance, release management rigor, and continuous improvement practices
Partner closely with Product, Architecture, Engineering, and Program teams to ensure seamless end-to-end delivery

Fulltime

Director, Product Quality Leader

This individual will serve as a technical quality expert for one or more product...

Location

United States

Salary:

164000.00 - 225500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or related field required
Advanced degree desirable
12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry
Preferred experience in biologics product development and licensure or technical support
Experience in both clinical and commercial phases of product lifecycle is highly desirable
Experience supporting combination products across clinical and commercial stages, including device quality considerations, is a plus
Excellent interpersonal and communications skills
Demonstrated strong leadership capability
Experience with influencing diverse stakeholders and driving accountability and decision-making in a highly matrixed, cross-functional environment
Highly capable of building strong, effective working teams

Job Responsibility

Serve as a technical quality expert for one or more products during clinical development through post-commercialization
Make technical quality-related decisions
Serve as the single point of contact on the CMC team for all quality functions, risks and issues
Provide efficient and effective quality leadership of CMC-related strategic activities
Drive associated quality decisions
Participate fully in CMC team meetings and other relevant technical forums
Partner with CMC Team and the Quality organization to identify, develop and prioritize long-term product strategies/initiatives
Accountable for creation of the product-specific Quality strategy
Lead the cross-functional Quality Partner Team (QPT) supporting Quality-related CMC deliverables
Own and manage the product quality risk register

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

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Quality Director

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