Director/Senior Director, Quality Assurance

nChroma Bio is a pioneering biotechnology company redefining the future of in vivo targeted genetic medicine to treat a wide array of diseases and bring cures to patients. The company’s integrated product engine tackles significant limitations of existing genetic medicine approaches by enabling safe, precise and specific in vivo delivery. nChroma’s near clinical-stage development candidate, CRMA-1001, is a liver-targeted therapy in development as a potential functional cure for chronic hepatitis B and hepatitis D that leverages the power of epigenetics, nature's innate mechanism for gene regulation. Guided by a world-class team at the forefront of genetic medicine, founded by renowned pioneers in the field, and supported by top-tier investors, the company is uniquely positioned to deliver groundbreaking therapies with programmable tissue specificity, unlocking highly potent, durable and targeted gene regulation for the liver and beyond.

We’re building a culture and organization to support this important mission, bringing together individuals that thrive in a supportive environment where diverse perspectives and a passion for discovery drive cutting-edge science and breakthrough medicines.

RESPONSIBILITIES:

The Director/Sr. Director, Quality Assurance will be responsible for implementing GxP (GCP/GLP/GMP) compliant Quality Management Systems, performing all required functions of the Quality Assurance Unit (i.e. product release) and building a Quality Assurance organization that fosters a strong Quality culture at nChroma Bio. This position will report to Head of Technology Development and partner equally with both internal and external stakeholders (CROs, CDMOs).

• Responsible for the strategic development and execution of nChroma’s quality assurance programs
• Responsible for all independent, quality-related decisions
• The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing nChroma’s platform technologies
• Establish and oversee controlled document management system
• Support development of regulatory processes, information management systems, and review of regulatory documentation as needed
• Collaborate with cross functional internal teams to develop processes, procedures and activities for adherence to relevant industry standards, regulatory guidelines and building out company Standard Operating Procedures (SOPs), as appropriate
• Establish and manage Quality and Compliance Training program for GxP employees and contractors
• Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions.
• Establish GxP Vendor Qualification program in accordance with regulatory expectations.
• GxP vendor Quality oversight, including product batch records, manufacturing investigations, vendor product release, stability programs, analytical method qualifications, etc.
• Ensure quality metrics comply with best industry standards and practices
• Establish quality governance and ensure continuous improvement for compliance
• Interpret and apply quality requirements; provide guidance and training to ensure company and vendors maintain GxP compliance

SKILLS & COMPETENCIES:

• Demonstrated ability to lead and influence cross-functional teams at a strategic level with strong negotiation and influencing skills, coupled with strategic thinking and a solution-oriented mindset
• Clear and adaptive communication, exceptional leadership, and a collaborative approach, fostering a constructive and team-based culture
• Excellent analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective
• Strong oral and written communication skills with experience presenting both internally across all levels of the organization and externally to other interested parties
• Ability to thrive in a fast-paced, innovative, and, at times, uncertain or changing environment while remaining flexible, proactive, and resourceful
• Adept at prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues, and balancing competing priorities effectively
• Collaborative and team-oriented mindset with a desire to positively impact a new company’s evolving culture
• Passionate, adaptable, and keen on working in the fast-paced biotech startup space to drive cutting-edge science

QUALIFICATIONS:

• BS degree in a scientific discipline is required; a post-graduate degree is highly desirable.
• A minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry. GLP/GCP experience will be a plus.
• Experience in building and executing Quality Assurance programs in the context of genomic medicine
• Expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulations across multiple jurisdictions
• Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices. Demonstrated knowledge of international regulatory requirements for biotech products and experience in disposition of biotech products to multiple jurisdictions.
• Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals
• Proven experience in leading quality assurance teams and managing complex quality systems.

nChroma Bio is an equal opportunity employer, providing equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, nChroma Bio complies with applicable state and local laws governing nondiscrimination in employment.