Director Quality Management Job at Cerament (Bonesupport) (Lund)

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Associate Director - Program Management – Quality & Compliance Programs (Hybrid)

Reporting into the PMO, the Associate Director – Program Management, Quality & C...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Experience in pharmaceutical or biotechnology industries is required
Advanced degree in Life Sciences is preferred
8+ years of experience in technical operations, specific project/program management experience required, C&GT, CAR-T or similar industry preferred
Direct experience supporting regulatory Health Authority Inspections in a GxP-regulated environment is required
Certification in project management (e.g., PMP, CAPM) is preferred
Experience with both early- and late-stage clinical programs is an advantage
Proficiency in MS Office (MS Outlook, PowerPoint, Excel, and Word)
familiarity with project management tools is required
Strong understanding of PM Best Practices, operating in a PMO and how to scale processes in a growing corporate environment is required
Extensive experience in utilization of Smartsheet including creation, maintenance, and reporting of timelines, Gantt charts, dashboards, and reports

Job Responsibility

Partner with various Program Leads of Quality programs to effectively manage the projects and programs
Schedule and lead team meetings including developing agendas, publishing meeting minutes and decision logs, and tracking action items to completion
Initiate and maintain cross-functional collaboration and communication, as needed, to drive project progress and team alignment
Prepare and present slide decks, project reporting and updates to senior management and other key stakeholders to inform and drive decision making
Work with Quality & Compliance Leadership Team to provide scenario planning and project reporting for all Quality & Compliance project management activities, aligning them with company goals and regulatory requirements, including the development and maintenance of charters, dashboards, trackers, schedules and other PM documentation
Routinely perform project planning and due diligence including development of scope, timeline, budget, and resource plan to Quality-focused and Enterprise project portfolio
Extensively support ongoing program management initiatives for the enterprise PMO by utilization and/or creation of project management tools and templates across the company contributing to a continuous improvement culture
Work extensively with the lead Asset PM to support our cross-functional Product Development Team Program (PDT) and the CABA-201 clinical program
Work closely with Clinical Teams, Regulatory Affairs, Technical Development and Supply Chain to support the preparation and submission of regulatory filings, including INDs, and BLAs
Work with all appropriate stakeholders to identify potential project risks, maintain risk registers, conduct risk assessments and develop mitigation strategies to address them proactively

What we offer

Health and retirement
PTO
Stock option plans

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

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

Director Ambulatory Quality Management

In a High- Reliability Organization, the Director of Ambulatory Quality is respo...

Location

United States , Irving

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Bachelor’s degree of Science in Nursing or other related field required
Five years of healthcare experience
Two years of management experience
Three years of quality management

Job Responsibility

Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders
Communicate effectively to different audiences
Proficient in computer skills using EXCEL, PowerPoint, MS Office, and Flowchart tools
Knowledgeable on High-Reliability Principles and PDSA methodology
Knowledgeable on payment models for quality metric performance

Fulltime

Executive Director, Quality Data Analytics and Process Management

In this vital role as the Executive Director, R&D Quality Data Analytics & Proce...

Location

United States , Thousand Oaks

Salary:

241843.70 - 327200.30 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 6 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Master's degree and 10 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
Bachelor's degree and 12 years of pharmaceutical/biotech quality systems, clinical quality, R&D operations, analytics, or process management
6 years of managerial experience directly leading people in a multi-tiered organization and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Job Responsibility

Develop and execute a multi-year strategy for process management, data analytics, document management, and risk management aligned to R&D Quality priorities
Serve as a strategic advisor to the Head of R&D Quality on process performance, clinical quality trends, operational risk, and digital opportunities
Build a high-performing organization focused on innovation, simplification, and measurable business impact
Act as business process owner for core R&D Quality processes such as deviations/nonconformances, CAPA, change control, training (metrics) and risk management
Support the R&D business process owners to develop global standards, process controls, KPIs, roles/responsibilities, and governance for assigned processes
Ensure simplification, standardization, and modernization of document structures and approval workflows in partnership with Global Quality
Ensure processes are compliant with applicable GxP regulations and integrated across functional boundaries
Lead periodic process reviews, health checks, and continuous improvement initiatives related to these processes
Establish a modern analytics strategy for R&D Quality using dashboards, predictive indicators, trend analysis, and self-service reporting tools
Develop executive dashboards for quality performance, compliance health, process efficiency, inspection readiness, and risk visibility

What we offer

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, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models where possible

Fulltime

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

Associate Director / Director, Data Management

Reporting to the Senior Director, Clinical Data Management, the Associate Direct...

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

BS or MS degree in a scientific or health-related field
10+ years of experience in clinical data management within pharmaceutical/biotech and/or CRO environments
Demonstrated sponsor-side ownership of Phase I, II and III studies, from start-up through closure for multiple clinical studies
Strong hands-on experience with EDC systems (e.g., Medidata RAVE, Veeva EDC, Oracle Inform)
Deep knowledge of CDASH/CDISC, GCP/ICH, and FDA regulatory expectations
Proven experience overseeing CROs and external data vendors
Experience developing reports using J-Review and/or other CDM reporting tools
Prior IND, as well as NDA/BLA (filing/submission) experience, is highly desirable
Must be self-motivating, with strong analytical, organizational, and communication skills, with the ability to manage complexity across multiple studies
Demonstrated ability to navigate evolving priorities and drive timelines forward with focus and composure in a fast-moving organization

Job Responsibility

Lead sponsor side clinical data management activities across multiple concurrent studies within a defined therapeutic area
Own data management execution from study start-up through database lock and archival for concurrent studies, including late stage and registrational trials
Ensure data quality, integrity, and traceability to support interim analyses, CSRs, DSURs, IB updates, and program specific regulatory interactions
Proactively identify data risks, trends, and operational dependencies
Serve as the primary data management contact for CROs and third-party data vendors
Oversee outsourced CDM activities to ensure timely, high-quality deliverables aligned with sponsor’ expectations
Monitor CRO and vendor performance, escalating risks and proposing mitigation strategies
Contribute expert input to the development and evolution of data management standards, processes, tools/systems and vendor operating models
Provide hands-on leadership for CRF design and cross functional review, Edit check specifications and user acceptance testing, Data Management Plans and CRF Completion Guidelines, External data transfer specifications
Apply CDASH/CDISC expertise and partner with Statistical Programming to support SDTM readiness, validation outputs, Reviewer’s Guides, and define.xml

Fulltime

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Director Quality Management

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