Quality Assurance Director, Clinical (Contractor/Temp)
Company: Tbwa Chiat/Day Inc
Location: Berkeley
Posted on: November 6, 2024
Job Description:
Quality Assurance Director, Clinical (Contractor/Temp)Caribou
Biosciences is a leading clinical-stage CRISPR genome-editing
biopharmaceutical company dedicated to developing transformative
therapies for patients with devastating diseases. Our
next-generation genome-editing technology enables superior
precision to develop cell therapies that are armored to potentially
improve activity against diseases. We believe the future of cell
therapy is off-the-shelf, and we are advancing our pipeline of
off-the-shelf, or allogeneic, cell therapies from our CAR-T cell
therapy platform as readily available treatments for patients with
hematologic malignancies and autoimmune diseases.Summary/Job
Purpose:Responsible for leading in the development, implementation
and maintenance of QA systems and activities supporting quality
oversight towards GCP, GLP, and PV operations. The incumbent will
assist in the development of quality systems to ensure clinical
trials are conducted in accordance with appropriate regulations,
guidelines, procedures, and protocols.The incumbent is also
responsible for developing specific internal procedures, training
of staff, and hosting regulatory inspections. The position involves
managing clinical quality operations and liaison of clinical
quality related issues with Company's functional areas. The
candidate will perform audits of service providers, study sites,
and internal processes.The successful candidate must have the
ability to execute QA tasks independently; effectively represent QA
in a GCP, PV, and GLP focused team settings and manage quality
related activities related to clinical vendors, investigator sites
and regulatory agencies. In addition, the candidate must actively
manage an appropriate level of inspection readiness of Company's
clinical stakeholders and act as a catalyst for continuous process
improvement.Responsibilities
- 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.
- Create and implement clinical quality risk management
strategies to identify, assess, and mitigate risks associated with
clinical development and operations. This involves conducting risk
assessments, developing risk mitigation plans, and overseeing their
implementation.
- Build training and approve curricula based on the key elements
of the Quality System; Provide leadership and oversight for
training programs related to pre-clinical, clinical and PV. Ensure
that employees and relevant stakeholders receive appropriate
training on quality standards, regulations, and procedures.
- Establish and monitor quality metrics and key performance
indicators for the effectiveness of pre-clinical, clinical, and PV
quality assurance activities. Prepare routine reports and
presentations for senior/executive management review highlighting
quality performance, trends, and areas for improvement. Assist with
tracking compliance audit trends and present to management.
- Collaborate with cross-functional teams, including
pre-clinical, clinical operations, regulatory affairs,
pharmacovigilance, and other relevant departments, to ensure
alignment and integration of quality assurance activities. Build
and maintain effective relationships with internal and external
stakeholders, including regulatory agencies and service
providers.
- Perform internal and external audits to ensure stakeholder
system compliance with existing policies and procedures, and
requirements, standards, and guidelines.
- Lead and/or manage additional Quality Assurance (GxP)
initiatives or programs as business needs evolve.Key Qualifications
- Undergraduate or graduate degree(s) in Biological Sciences,
Chemistry, or related Science discipline with 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.
- Excellent verbal and written communication skills, ability to
lead cross-functional teams and independently prioritize work,
manage multiple projects while maintaining quality and being an
advocate for quality and regulatory compliance.
- The position requires a highly diplomatic, and tactful
individual with excellent critical reasoning skills.
- Conscientiously detail-oriented and organized, impeccable
attention to data review.
- Ability to deal with ambiguity and use expertise and skills to
contribute to the development of company objectives and principles,
and to achieve goals in creative and effective ways.
- Must be flexible and able to multi-task, prioritize, meet
deadlines in a fast-paced environment, and be adaptable to
setbacks.
- Detail-oriented mindset with a proactive approach to
problem-solving and decision-making.
- Certification in quality assurance (e.g., Certified Quality
Auditor) and/or GCP (e.g., Certified Clinical Research
Professional) is desirable.This position is for a temporary or
contract employee who will not be directly employed by Caribou
Biosciences. Instead, the individual will be an employee of a
third-party staffing firm and their work activities will be managed
by the Caribou team. As a temporary/contract employee, you will
collaborate closely with Caribou's internal teams and contribute to
our mission while reporting and getting supported by the staffing
firm. The compensation amount of this role will be based on the
budget and duration of the contract.
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Keywords: Tbwa Chiat/Day Inc, Laguna , Quality Assurance Director, Clinical (Contractor/Temp), Accounting, Auditing , Berkeley, California
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