BBOT · 3 hours ago
Associate Director, Quality
United States
Full-time
Remote
Lead/Staff, Director/Executive
$181K/yr - $204K/yr
10+ years expBBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. The Associate Director Quality will develop and implement Quality Assurance strategies to support the manufacturing, testing, and release of pharmaceutical products in compliance with GMP regulations.
Biotechnology
Responsibilities
Partner with the Executive Director, QA to develop and implement comprehensive Quality Assurance strategies to support the manufacturing, testing, and release of pharmaceutical products in accordance with GMP regulations and other relevant standards. Contributes to the strategy and approach for all inspection/ audits in compliance with local and global regulatory agencies. Performs lot release activities across all products
Collaborate with cross-functional teams, including Research and Development, Discovery, Regulatory Affairs, Manufacturing, Clinical Operations, and Supply Chain, to ensure seamless integration of quality processes throughout the product life cycle in alignment with GMP requirements
Conduct risk assessments and implement proactive measures to prevent and address quality issues, deviations, and non-conformances within the GMP context
Support regulatory inspections, ensuring readiness and effective responses to inspection findings, with a focus on GMP compliance
Establish and maintain key performance indicators (KPIs) to monitor and report on the effectiveness of the Quality Assurance program within the GMP framework
Drive the development and execution of training programs to enhance the skills and knowledge of quality personnel and other relevant stakeholders, with emphasis on GMP principles
Drive continuous improvement initiatives across the organization to increase compliance and / or productivity
Supports IND and NDA CMC module authoring, review and QC, supports responses to requests for information from regulatory agencies; supports the creation of reports and documentation needed for regulators and actively scans quality landscape to ensure alignment and identify laws and regulations that impact the company’s policies
Collaborate on appropriate change and communication approach as needed, manage changes in systems or procedures when necessary, and provide GMP Quality Assurance oversight of vendors, requalification and quality agreements
Responsible for supporting Quality Operations in Batch record review, OOS, deviations, change controls and product complaint investigations and GMP archives. Support continuous improvement of the quality system to ensure product reliability, quality, efficacy, and compliance. Oversees compliance auditing program to fulfill regulatory requirements
Follow applicable regulations, including FDA, ICH, and applicable Regulatory / Health Authorities
Support commercialization initiatives including implementation of Drug Supply Chain Security Act (DSCSA) serialization, develop commercial stage SOPs and Policies, and regulatory submissions
Qualification
Required
Bachelor's degree in life sciences or a related field required
10+ years of progressive GMP-related experience in QA, clinical development lifecycle oversight, clinical study monitoring, and vendor management
In-depth knowledge of global GCP regulations, ICH guidelines, and regulatory inspection practices
Strong leadership, organizational, and project management skills with ability to prioritize in a fast-paced environment
Excellent written and verbal communication for internal and external interactions
Deep understanding and experience in adopting a risk-based approach for problem-solving, root cause analysis, and strategic thinking balanced with attention to detail
Collaborative mindset with a proactive, 'can-do' approach
Preferred
Experience in preparing for, participating in global GxP inspections strongly preferred
Benefits
Annual bonus
Stock-based long-term incentives
Medical, dental, and vision benefits
Retirement
Wellness stipend
Flexible time off
Company
BBOT
BBOT (BridgeBio Oncology Therapeutics) is a clinical-stage biopharmaceutical company advancing a next generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies.
51-200 employees
H1B Sponsorship
BBOT has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase