Director of Quality Control Job at Daley and Associates (Lowell)

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

Director of Quality

Location

United States , Elk Grove Village

Salary:

140000.00 - 160000.00 USD / Year

Goodwin Recruiting

Expiration Date

Until further notice

Requirements

Eight plus years of progressive operations leadership in manufacturing
Aerospace defense precision machining or other regulated manufacturing experience strongly preferred
Proven success leading multiple functions including production quality and supply chain
Strong ERP or MRP systems experience
Working knowledge of AS9100 ITAR and export control requirements preferred
Demonstrated lean and continuous improvement leadership in a fast paced operation
Bachelor degree in engineering operations business or a related field preferred
Strong financial analytical and people leadership skills with the ability to build accountability and culture

Job Responsibility

Own full site performance across safety quality delivery cost and people
Direct daily operations across machining assembly and support functions to meet customer commitments
Lead and develop functional managers across production quality supply chain engineering and maintenance
Drive on time delivery schedule adherence and recovery on jobs at risk using ERP and site reporting
Manage the site operating budget and drive efficiency margin and cost performance
Maintain compliance with the AS9100 Rev D quality system ITAR and US export control requirements
Lead lean and continuous improvement across equipment uptime throughput and lights out machining

What we offer

Medical dental and vision insurance
Competitive compensation with bonus opportunities
401k with company match
Company paid short and long term disability and life insurance
Generous paid holidays and vacation time
Tuition reimbursement and professional development
Collaborative high performance aerospace and defense environment

Fulltime

Director of Quality Management

Director of Quality Management - Join Our Big-Hearted Team. Are you ready to mak...

Location

United States , Sun City

Salary:

89500.00 - 98815.23 USD / Year

Sun Health

Expiration Date

Until further notice

Requirements

Registered Nurse currently licensed by the State of Arizona
Must have completed an approved Infection Preventionist Certification or the ability to obtain certification within three (3) months from date of hire
Management experience preferred
Must maintain negative tuberculosis at hire and annually during employment
Flu shot and relevant immunizations are required
Must have current CPR certification. CPR certification must remain current during employment. Clinical Other/BCLS - Basic Life Support Current BLS, PALS and or ACLS
Possess current or has the ability to obtain an Arizona Identity Verified Prints (IVP) Fingerprint Clearance Card is required

Job Responsibility

Responsible for assisting in implementation of proper QA processes to support positive quality measures that impact the 5 Star rating as well as other areas of documentation of care by all staff for all residents
Provide direction and coordination of quality improvement activities, demonstrating knowledge of resident care, utilizing QAPI and performance improvement project principles
Monitor the development and implementation of documentation processes to ensure compliance with state and federal regulations by the nursing staff and other medical staff
Assist in the development of best practices across the organization
Assists in coordinating risk prevention strategies, including safety and regulatory compliance, training, and oversight
Responsible for monitoring, evaluating, and making recommendations regarding infection control, accidents and incidents, and pressure ulcers
Assist the Director of Nursing Services (DON) and the ADON, if applicable, in the development and revision of nursing policies and procedures in order to ensure best practice as well as ongoing compliance with current Federal and State regulations
Responsible for assisting in screening prospective residents, as needed
Participate in developing, orienting, and training of all nursing personnel on the process and programs necessary to meet regulatory requirements and standards of practice for Sun Health Senior Living
Assist in the development of orientation and training programs in conjunction with Sun Health's onboarding process

What we offer

Comprehensive health benefits (Medical, Dental & Vision)
401k with immediate vesting and up to 4% employer match
Tuition Reimbursement
Exclusive discounts through The Employee Network
Access to the Employee Association, supporting team members in need
Eligible for up to 20% base salary variable pay program

Fulltime

Quality Control Director

The Quality Control Director is responsible for leading Quality Control laborato...

Location

United States , Marietta

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or technical discipline (e.g., Chemistry, Biochemistry, Microbiology, or related field)
Minimum of 10 years experience working in a regulated GMP environment
Demonstrated experience in Quality Control laboratory operations
Experience supporting regulatory inspections and audits
Working knowledge of quality systems and regulatory expectations
Demonstrated ability to lead teams and work cross-functionally to manage priorities and deliver results

Job Responsibility

Lead and oversee Quality Control laboratory operations supporting GMP testing, release, and stability programs
Ensure laboratories are inspection-ready and operate in compliance with regulatory and quality system requirements
Provide leadership for QC readiness activities related to new product introductions, technology transfers, and lifecycle changes
Oversee method transfer and assay qualification activities in alignment with technical and regulatory requirements
Ensure effective QC organizational readiness, including staffing, training, onboarding, and capability development
Support QC involvement in commissioning, qualification, and validation activities for laboratory facilities, equipment, and systems
Ensure laboratory data integrity, documentation accuracy, and adherence to ALCOA principles
Partner with Manufacturing, QA, Engineering, Validation, and Development to support site priorities
Support internal and external audits and regulatory inspections
Contribute to continuous improvement initiatives and operational excellence within the QC organization

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Director of Quality

X-Bow Systems is hiring a Director of Quality to lead, manage, and run Quality f...

Location

United States , Luling

Salary:

200000.00 - 275000.00 USD / Year

X-Bow Systems

Expiration Date

Until further notice

Requirements

Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, or a related technical field
10+ years of progressive quality leadership experience in defense, aerospace, propulsion, energetics, or another highly regulated manufacturing environment
5+ years of experience as a people manager leading quality teams at the senior manager or director level, with direct supervisory responsibility for a meaningful-sized organization rather than a small team of individual contributors
Deep knowledge of AS9100, ISO 9001, audit systems, corrective action, nonconformance control, supplier quality, and configuration-controlled manufacturing
Experience supporting U.S. government contracts and operating in highly regulated production environments
Strong understanding of inspection systems, process validation, first article inspection, traceability, and risk-based quality management
Proven ability to lead root cause investigations, drive corrective action, and improve quality performance in complex technical operations
Strong leadership, judgment, and cross-functional influence, with the ability to lead through managers and supervisors and hold teams accountable across functions and locations
U.S. Person status and ability to obtain or maintain any required security clearance or access authorization
Master's degree in Engineering, Operations, Quality, or Business Administration

Job Responsibility

Lead the company's quality organization across quality assurance, quality control, supplier quality, audit readiness, nonconformance management, and corrective action
Set quality strategy, objectives, and performance expectations aligned with operational goals, customer requirements, and company growth
Advise the COO and executive leadership on quality risks, systemic issues, compliance gaps, and improvement priorities
Own and maintain the Quality Management System across relevant operations, facilities, and programs
Ensure compliance with AS9100, ISO 9001, customer requirements, contract flow-downs, and applicable FAR/DFARS requirements
Lead internal, customer, third-party, and regulatory audit activity and maintain audit readiness
Ensure effective controls for documentation, traceability, inspection, testing, calibration, configuration control, and records retention
Lead receiving, in-process, and final inspection strategies to ensure product conformity and process discipline
Own nonconformance, containment, root cause, corrective action, and verification of effectiveness across internal and supplier issues
Improve quality performance using metrics including yield, escapes, rework, scrap, supplier defects, audit findings, and cost of poor quality

Fulltime

Director of Quality Management

To ensure proper monitoring, tracking, and reporting of all nursing quality assu...

Location

United States , Sun City

Salary:

89500.00 - 98815.23 USD / Year

Sun Health

Expiration Date

Until further notice

Requirements

Registered Nurse currently licensed by the State of Arizona
Must have completed an approved Infection Preventionist Certification or the ability to obtain certification within three (3) months from date of hire
Must maintain negative tuberculosis at hire and annually during employment
Flu shot and relevant immunizations are required
Must have current CPR certification. CPR certification must remain current during employment. Clinical Other/BCLS - Basic Life Support Current BLS, PALS and or ACLS
Possess current or has the ability to obtain an Arizona Identity Verified Prints (IVP) Fingerprint Clearance Card is required

Job Responsibility

Responsible for assisting in implementation of proper QA processes to support positive quality measures that impact the 5 Star rating as well as other areas of documentation of care by all staff for all residents
Provide direction and coordination of quality improvement activities, demonstrating knowledge of resident care, utilizing QAPI and performance improvement project principles
Monitor the development and implementation of documentation processes to ensure compliance with state and federal regulations by the nursing staff and other medical staff. Assist in the development of best practices across the organization
Assists in coordinating risk prevention strategies, including safety and regulatory compliance, training, and oversight
Responsible for monitoring, evaluating, and making recommendations regarding infection control, accidents and incidents, and pressure ulcers
Assist the Director of Nursing Services (DON) and the ADON, if applicable, in the development and revision of nursing policies and procedures in order to ensure best practice as well as ongoing compliance with current Federal and State regulations
Responsible for assisting in screening prospective residents, as needed
Participate in developing, orienting, and training of all nursing personnel on the process and programs necessary to meet regulatory requirements and standards of practice for Sun Health Senior Living
Assist in the development of orientation and training programs in conjunction with Sun Health's onboarding process
Provide campus wide quality assurance direction, education, and resource support as needed

What we offer

Comprehensive health benefits (Medical, Dental & Vision)
401k with immediate vesting and up to 4% employer match
Tuition Reimbursement
Exclusive discounts through The Employee Network
Access to the Employee Association, supporting team members in need
Eligible for up to 20% base salary variable pay program

Fulltime

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Director of Quality

Mantell Associates is partnered exclusively with a globally operating CDMO to re...

Location

United States , Massachusetts

Salary:

Not provided

Mantell Associates

Expiration Date

Until further notice

Requirements

Significant quality leadership experience within a CDMO, pharmaceutical or biotechnology manufacturing environment – CDMO experience strongly preferred
Proven experience leading site-level quality operations at scale, ideally within a large, complex GMP manufacturing facility
Hands-on experience across both biologics/mAb and small molecule modalities
Deep knowledge of FDA GMP regulations (21 CFR Parts 210/211/600) and relevant ICH guidelines
Demonstrated experience managing FDA inspections with a strong track record of successful outcomes
Proven QC oversight experience, with a solid understanding of analytical operations and laboratory compliance
Strong client-facing skills with the ability to build credibility and trust at a senior level
Exceptional leadership and people management skills, with experience developing large, diverse quality teams
Strategic thinker with the operational presence to engage credibly at all levels of a large manufacturing site
Bachelor’s degree or above in a relevant life sciences discipline

Job Responsibility

Own and drive the site QMS, ensuring all systems, processes and documentation are robust, inspection-ready and aligned with global quality standards
Lead site GMP compliance across biologics/mAb and small molecule manufacturing operations, ensuring adherence to FDA regulations and ICH guidelines
Oversee the site CAPA programme, deviation management and change control processes, ensuring issues are investigated thoroughly and resolved effectively
Drive a proactive, right-first-time quality culture across all site functions, from manufacturing and QC through to supply chain and engineering
Provide strategic and operational oversight of the site QC function, ensuring analytical testing, raw data review and results reporting meet the highest standards of accuracy and compliance
Partner with QC leadership to ensure laboratory operations are fully compliant, inspection-ready and continuously improving
Oversee out-of-specification (OOS) and out-of-trend (OOT) investigations, ensuring robust root cause analysis and appropriate corrective actions
Serve as the site quality authority for all regulatory matters, leading preparation for and management of FDA inspections and any other relevant agency interactions
Provide quality oversight and input into regulatory submissions, ensuring site-level documentation and data packages meet agency expectations
Monitor the evolving regulatory landscape and proactively update site quality systems and practices to maintain compliance

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Director of Quality Control

Job Description

Job Responsibility

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What we offer

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