Quality Control Director Job at GSK (Marietta)

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

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

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

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

Quality Control Director – Commercial

Your career matters at Caddell, where there is a strong emphasis on the growth a...

Location

United States , Bentonville; Jacksonville; Phoenix; Woodstock; Montgomery

Salary:

Not provided

Caddell Construction

Expiration Date

Until further notice

Requirements

Deep knowledge of building codes, industry standards, and testing/inspection protocols
Proven ability to lead enterprise-wide programs and influence senior stakeholders
Strong communication, organizational, and leadership skills
Proficiency with Procore and Microsoft Office Suite
Professional certifications strongly preferred
Minimum college or technical degree and 15 years total construction management experience
Four-year degree in building science, construction management or engineering and fifteen years’ total construction management experience preferred
Advanced degree in Engineering and Business Administration preferred
5–7 years in a senior corporate or divisional quality leadership role preferred

Job Responsibility

Has leadership responsibility for setting expectations and providing guidance to Quality Control Managers at all commercial project locations
Directs the overall quality direction of the organization and the effectiveness of the quality control program (QCP)
Ensures that company standards, as outlined in the Caddell Quality Control Manual are effectively implemented and provides notification to corporate management of quality problems
Drive continuous improvement philosophy by ensuring that the QCP is understood, followed, measured and communicated regularly
Develops KPI (Key Performance Indicator) goals and supporting strategy in aligning improvement targets and organizational objectives
Leads cross functional teams engaged in identifying and resolving quality issues impacting raw material and product quality, ensuring owner satisfaction
Ensures adequate corrective measures are implemented in cases of noncompliance
Oversees the development and implementation of inspection criteria and procedures
Maintains an attitude conducive to progress through positive change, continuous improvement, and an active contribution to teamwork concepts
Oversee field quality execution through Quality Managers, Superintendents, Project Managers, and third-party inspectors

What we offer

Paid vacations
company paid holidays
company joint funding of medical, dental, and vision insurance
life and disability plans to full-time employees
401k
gym membership reimbursement
use of company condominiums

Fulltime

Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in ...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
Excellent communication skills with an ability to collaborate effectively across functional lines
Ability to work independently and multi-task in 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
Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations
Partner with global and cross-functional teams to ensure successful implementation of harmonized methods
Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements
Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues
Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines
Generate and review technical documents, including protocols, reports, and method lifecycle documents

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

Director of Quality Control

This is a hands-on leadership role for someone who can both set strategy and dri...

Location

United States , Lowell

Salary:

180000.00 - 220000.00 USD / Year

Daley and Associates

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Engineering (preferred)
10+ years of experience in Quality Assurance within industrial or heavy manufacturing environments
Proven experience leading and developing Quality teams (manager-of-managers or senior leadership level)
Hands-on experience implementing or rebuilding a QMS, not just maintaining documentation
Strong background in welded fabrication, engineered-to-order manufacturing, or highly regulated industrial production
Demonstrated success driving corrective action and preventing repeat quality failures
Comfortable operating in a hands-on, shop-floor-focused environment
Strong leadership, communication, and cross-functional collaboration skills

Job Responsibility

Own and lead the Quality Assurance function end-to-end, including team leadership and third-party inspection oversight
Implement, execute, and continuously improve a robust Quality Management System (QMS)
Drive corrective and preventive action, root-cause analysis, and non-conformance resolution
Ensure compliance with applicable industry codes, standards, and customer requirements
Partner closely with operations and production leadership to proactively support complex, engineered-to-order projects
Maintain strong shop-floor presence while collaborating with senior leadership
Lead audits, inspections, and quality reviews with customers and external parties
Build a culture of accountability, continuous improvement, and quality ownership across the organization

What we offer

bonus

Fulltime

Senior Director, Analytical Development and Quality Control

The Altos Institute of Medicine will capture knowledge generated about cell heal...

Location

United States , Redwood City

Salary:

283900.00 - 384100.00 USD / Year

Altos Labs

Expiration Date

Until further notice

Requirements

Ph.D. in analytical sciences or biological sciences
Minimum 15+ years of analytical development and QC experience in biotech/pharmaceutical industry
10+ years of Management experience
Highly experienced in developing and implementing assays for Quality Control testing and characterization of drug substance, drug product and manufacturing in-process samples
Experienced in multiple modalities including biologics, oligonucleotides, small molecules, mRNA/LNP and AAV gene therapy
Experienced in leading CMC team and analytical subteam
Proficient in cGMP’s and pharmaceutical industry procedures and regulations
Highly experienced in achieving CMC deliverables through outsourcing to Contract Manufacturing Organizations
Leadership experience in managing diverse project activities with contract CDMO facilities at global locations
A critical thinker with the ability to analyze possibilities and solutions and make pragmatic trade-offs

Job Responsibility

Lead analytical development and quality control across multiple modalities
Build a high performing team and establish internal and external analytical and QC capabilities
Serve as CMC lead and analytical lead for Altos therapeutic programs
Manage contract manufacturing organizations and CROs to develop and qualify analytical testing methods, perform product characterization, release and stability testing, and in-process testing
Establish product specifications to ensure product quality
Support technical assessment of Out of Specification and Non-Conforming investigations
Author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents
As a member of the Tech Ops leadership team, build the Tech Ops organization, processes, systems and infrastructure
Create and foster strong partnerships with Institutes of Science, Institutes of Technology, Institute of Computation, drug discovery and development sciences, clinical, regulatory, program management, business development, legal and finance
Actively contribute to a team culture that promotes continuous improvement, accountability, professional growth, and inclusion

Fulltime

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