Associate Director / Director, Clinical Quality Assurance Job at Beam Therapeutics (Cambridge)

Associate Director, Clinical Quality Assurance

We are seeking a dynamic and results-driven Associate Director of Clinical Quali...

Location

United States

Salary:

170000.00 - 190000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor's degree in a relevant biological sciences or equivalent is required, advanced degree a plus
8-10 years professional experience in Quality Assurance within the biopharma industry, including increasing responsibilities in the Clinical QA function
Minimum of 6 years of direct audit experience in GCP
In-depth working knowledge of GCP regulations and guidelines, including FDA, EMA, and ICH requirements
Extensive experience using electronic QMS to monitor, report, and track quality tasks and key quality performance indicators
Strong communication (oral and written), effective interpersonal skills with the ability to listen and drive change
Excellent problem-solving and critical thinking abilities
Flexible and creative to meet the needs and challenges of a growing, dynamic company
Focus on fostering a culture of collaboration and teamwork
Ability to manage multiple projects with aggressive timelines and changing priorities

Job Responsibility

Assist CQA Leadership with development and execution of CQA audit plans supporting Apogee clinical study programs
Perform or provide oversight of assigned GCP audits e.g. clinical investigator sites, clinical vendor qualifications, trial master files, internal processes and clinical study documents with minimal supervision
Act as CQA lead representative at clinical study team meetings and other study related meetings
Partner with clinical functions to provide quality guidance as required to drive the implementation of fit for purpose procedures that support clinical data and documentation generated activities are executed in compliance with GCP
Facilitate and/or review the investigation of reported quality events to evaluate the appropriateness of CAPAs proposed to mitigate risk of issue re-occurrence
Contribute to the development and maintenance of clinical QA procedures and other governance standards as assigned
Assist in the periodic reporting of key quality metrics to leadership to assist in driving improvements in GCP compliance across the organization
Assist in the development and/or delivery of GCP training topics and quality standards as directed
Assist QA Leadership in fostering a culture of quality and continuous improvement within the organization, emphasizing the importance of compliance, data integrity, and patient safety in support of corporate goals
Collaborate with clinical functions to support inspection readiness activities

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including 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 Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

Associate Director, Product Quality Assurance

The Associate Director of Product Quality for Cell and Gene Therapy Programs wil...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelors or Advanced degree in scientific discipline
12+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role
Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements
Ability to influence without direct authority
Ability to develop into a primary PQL for Beam programs
Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
Experience interacting with regulatory health authorities at pre- and post-approval inspection
Strong team player that has a customer service approach and is solution oriented
Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
Excellent listening, communication and interpersonal skills fostering team spirit

Job Responsibility

Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments
Drives and takes action on Phase Appropriate Quality strategy for Beam’s products
Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation
Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc
Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL
Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives
Support clinical to commercial analytical control strategy
Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.)
Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations

Fulltime

Associate Director of Quality

We are seeking an experienced and values-driven Associate Director of Quality to...

Location

United Kingdom , East Midlands

Salary:

Not provided

Kisimul

Expiration Date

Until further notice

Requirements

Senior leadership experience in quality, compliance or governance within regulated services
A qualified clinical practitioner, with significant demonstratable expertise in the leadership and management of adults and/or children’s social care and education
In-depth knowledge of CQC, Ofsted and relevant legislation and frameworks
Proven experience in ensuring inspection readiness, leading inspections and driving service improvement
Strong analytical, influencing and communication skills
Ability to work collaboratively across multiple services and locations

Job Responsibility

Support and drive colleagues and teams to ensure the people we support and educate are supported to have truly meaningful lives via a trauma informed and person centred approach
Provide leadership and oversight of quality, regulatory compliance and practice governance across the Group
Lead on regulatory compliance, inspection readiness and engagement with bodies such as CQC and Ofsted
Drive and support services to achieve and sustain regulatory ratings of Good or Outstanding
Develop, implement and monitor quality assurance frameworks, audits and improvement plans
Analyse quality and performance data to identify risks, trends and opportunities for improvement
Promote a strong safeguarding culture, ensuring robust systems and practices are in place
Coach and support senior leaders and managers to embed best practice and continuous improvement
Contribute to strategic planning and organisational development at a senior level

What we offer

Opportunity to make a meaningful impact on people’s lives
Supportive, values-led organisation with a strong commitment to quality
Competitive salary and benefits package
Ongoing professional development and career progression
Flexible and hybrid working opportunities

Fulltime

Senior Manager / Associate Director, Manufacturing

Beam is looking for a highly energetic Sr Manager/Associate Director, Manufactur...

Location

United States , Durham, NC

Salary:

155000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree preferably with a science or engineering focus and a minimum of 10 years of Manufacturing and Operations experience
At least 2 years experience leading and developing people in a GMP setting
Experience working cross-functionally building and maintaining strong relationships
Autologous cell therapy experience strongly preferred

Job Responsibility

Cultivate Beam’s culture and our values-driven organization focused on people
Execute against the mission, vision, and strategy for Beam internal cGMP Manufacturing
Ensure safety, compliance, efficiency, and sustainability throughout cGMP operations
Lead and coordinate resources to ensure quality standards are met and products are delivered on time and within budget
Champion development of a learning culture that embraces innovation and continuous improvement
Prepare and maintain departmental budget and workforce model in partnership with the Director of Manufacturing
Support establishment of long range and business continuity plans
Manage and support up to but not limited to multiple areas of GMP production as needed
Develop and implement metrics/KPIs to monitor operational health, inform strategic decisions
Build collaborative and empowered teams that put patients first

Fulltime

Director Clinical Services

The Director, Clinical Services is responsible for the planning, direction, coor...

Location

United States , Lexington

Salary:

42.99 - 63.95 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Current RN license (BSN preferred), Physical Therapist license, or Occupational Therapist license in good standing
CPR or BLS certification (current)
Three years of management experience required
Two years of home care or hospice experience required
one year in hospital nursing preferred

Job Responsibility

Mission & Values Adherence: Champion CHI Health at Home and CommonSpirit Health's mission, values, strategic goals, and high standards of customer service
Ethical Conduct & Compliance: Uphold the Corporate Compliance Program
Operational Support: Provide prompt and professional assistance to office and clinical staff
Quality Care Oversight: Direct the accurate, complete, and timely provision of quality patient care and services, ensuring individualized patient plans of care are appropriate and in compliance with all regulatory, operational, and financial requirements
Clinical Record Compliance: Assure the accuracy, completeness, and timeliness of all clinical records, meeting regulatory, operational, and financial requirements
EMR Workflow Completion: Guarantee that all HCHB clinical workflow for both the Director of Clinical Services (DCS) and Manager of Clinical Services (MCS) is completed and current by the end of each business day
Outcome Monitoring & Improvement: Monitor clinical outcome results (utilizing SHP and company data), develop, and implement plans for continuous improvement
Clinical Performance Management: Monitor and evaluate clinical performance measures, including productivity standards, documentation completion standards, and patient care management, developing and implementing action plans based on results
Clinical Documentation Expertise: Ensure the ongoing development of clinical employee knowledge, understanding, and appropriate completion of OASIS, initial and ongoing physician orders, and all other clinical documentation tools
Information Dissemination: Ensure accurate, complete, and timely communication of regulatory, operational, and financial information to clinical and applicable office associates

What we offer

Generous annual bonus opportunity based on company performance
Excellent holiday and paid time off plans
Medical, dental, and vision plans
Tuition reimbursement for degree-seeking students
Employer contribution to your 401(k)

Fulltime

Director Clinical Services Hospice

At CHI Health at Home, we strive to embody our mission of delivering hope and he...

Location

United States , Omaha

Salary:

42.99 - 63.95 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Current RN license (BSN preferred), Physical Therapist license, or Occupational Therapist license in good standing
CPR or BLS certification (current)
Three years of management experience required
Two years of hospice experience required
One year in hospital nursing preferred

Job Responsibility

Planning, direction, coordination, supervision, evaluation and provision of all clinical services provided by the assigned facility location
Champion mission, values, strategic goals, and high standards of customer service
Uphold the Corporate Compliance Program
Provide prompt and professional assistance to office and clinical staff
Direct the accurate, complete, and timely provision of quality patient care and services
Assure the accuracy, completeness, and timeliness of all clinical records
Guarantee that all HCHB clinical workflow for both the Director of Clinical Services (DCS) and Manager of Clinical Services (MCS) is completed and current by the end of each business day
Monitor clinical outcome results, develop, and implement plans for continuous improvement
Monitor and evaluate clinical performance measures, including productivity standards, documentation completion standards, and patient care management
Ensure the ongoing development of clinical employee knowledge, understanding, and appropriate completion of OASIS, initial and ongoing physician orders, and all other clinical documentation tools

What we offer

Generous annual bonus opportunity based on company performance
Excellent holiday and paid time off plans
Medical, dental, and vision plans
Tuition reimbursement for degree-seeking students
Employer contribution to your 401(k)

Fulltime

Director Clinical Services

At CommonSpirit Health at Home, we strive to embody our mission of delivering ho...

Location

United States , Elizabethtown

Salary:

42.99 - 63.95 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Current RN license (BSN preferred), Physical Therapist license, or Occupational Therapist license in good standing
CPR or BLS certification (current)
Three years of management experience required
Two years of home care or hospice experience required
One year in hospital nursing preferred

Job Responsibility

Planning, direction, coordination, supervision, evaluation and provision of all clinical services provided by the assigned facility location
Champion CHI Health at Home and CommonSpirit Health's mission, values, strategic goals, and high standards of customer service
Uphold the Corporate Compliance Program
Provide prompt and professional assistance to office and clinical staff
Direct the accurate, complete, and timely provision of quality patient care and services
Assure the accuracy, completeness, and timeliness of all clinical records
Guarantee that all HCHB clinical workflow for both the Director of Clinical Services (DCS) and Manager of Clinical Services (MCS) is completed and current by the end of each business day
Monitor clinical outcome results, develop, and implement plans for continuous improvement
Monitor and evaluate clinical performance measures
Ensure the ongoing development of clinical employee knowledge, understanding, and appropriate completion of OASIS, initial and ongoing physician orders, and all other clinical documentation tools

What we offer

Generous annual bonus opportunity based on company performance
Excellent holiday and paid time off plans
Medical, dental, and vision plans
Tuition reimbursement for degree-seeking students
Employer contribution to your 401(k)

Fulltime

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