Director, Quality Assurance & Compliance

Director, Quality Assurance & Compliance

Pittsburgh, PA

Job Title: Director, QA & Compliance
FLSA Status: Full-Time/Exempt
Department: Quality Assurance
Date: April 1, 2022
Manager: Vice President, Quality Assurance
Location: Pittsburgh, PA or Remote
Job Code: BIO-22-027

BlueSphere Bio was founded to deploy its novel TCXpress™ technology to unlock the potential of personalized T cell therapy for the treatment of cancer by harnessing the unique specificity of each patient’s T cells for the molecular fingerprint of each patient’s cancer.

Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.

The TCXpress™ platform and its implementation will allow us to deliver rapid, personalized T cell treatments for various cancer indications.

The Director of QA & Compliance is responsible for building and leading successful quality assurance and regulatory compliance programs supporting BlueSphere Bio’s (BSB) research and clinical platforms.

The QA Director is responsible for developing and implementing quality assurance standards via policies and procedures, training, system auditing, and monitoring, facilitating internal reporting, and overseeing gap analyses and related CAPA implementation. Additionally, this role will work closely with and collaborate with the other BSB leaders to identify, build and support quality assurance initiatives. The Director, QA & Compliance, will report to the VP, Quality Assurance, and ideally will be located in Pittsburgh, Pennsylvania. However, we will consider remote applications.

Duties and Responsibilities

QA Operations
• Oversees and supports the design, implementation, and documentation of staff training requirements, based on current industry standards, new or complex government regulations, and guidance.
• Develop, design, and implement education programs based on tracking and trending audit results and findings.
• Manage the internal QMS audit function and ensure that robust QMS systems are in place, including controlled document workflows, training, auditing activities, risk identification/deviations, and CAPA development.
• Remain abreast of the status of all quality assurance activities and identify trends, identify potential areas of deviation; develop and/or implement policies and procedures for the resolutions of all issues and complaints.
• Ensure that internal reporting mechanisms are developed, implemented, maintained, and actively monitored.
• Responsible for the maintenance of training records on policies, SOPs, and associated processes and procedures of employees and communicating with department heads when updates are needed.
• Performs disposition activities in support of Clinical Product including Master and Executed Batch Record review and approvals
• Leads in evaluations of Investigations/ OOS/ Change Controls. Supports root-cause analysis and product impact assessment for investigations.
• Reviews and manages product release and stability data.
• Ensures compliance to cGMP, policies, and procedures for internal and external operations supporting clinical drug product
• Provides Quality oversight of CMO operations for drug substances and drug products, including the approval of protocols, starting material and finished product specifications, manufacturing, analytical, and stability reports. Other duties as assigned

Key Stakeholder Partnerships
• Collaborate with all leaders within BSB to direct quality assurance and compliance issues to appropriate channels for investigation and resolution.
• Participate in process improvement initiatives, including suggesting or evaluating revisions.
• Communicate with and provide updates to Senior Leadership and Compliance to ensure the business is aware of any potential risks, including all identified CAPA plans

People Leadership
• May supervise and or direct the work of outside workers, select site staff, and or professional consultants.

Qualifications and Work Experience
• Minimum of 12 years of experience within the pharmaceutical industry with 10+ years in a Quality Assurance role.
• Cell and Gene Therapy or Biotech experience preferred.
• Broad GMP Knowledge and understanding across the lifecycle of the product.
• 21 CFR Part 11 / Annex 11 Computer System Validation is a plus.
• Experience managing FDA and/or life science sponsor audits
• 4+ years of people leadership experience (building and developing high-performing teams)
• 4-year degree in a science-related field. Advanced degree preferred (MBA, MS) a plus
• Experience building QMS and compliance programs
• Thorough, working knowledge of Federal Regulations and Guidance within the healthcare industry
• Attention to detail, solid execution, meeting aggressive timelines, strong interpersonal skills, and team player
• Excellent verbal and written communication skills
• Ability to establish operational plans and strategies. Requires a balance of scientific and operational/project management and team leadership expertise.
• Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment

BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.

Please send a cover letter to apply for this position (including job code) and CV/Resume. Internal candidates interested in this opportunity should submit their CV/Resume within 2-weeks of the posting date above and explain why you are interested in this position.

BlueSphere Bio