Director, Quality Assurance
Emeryville, CA /
Quality /
Full-Time
/ On-site
Pick a challenge that is bigger than your lifetime.
New ideas are all around us, but only a few will change the world. That’s our focus at Nutcracker. We are an early-stage company looking at mRNA and its production in a completely different way. We are challenging the conventional and merging both innovative science with engineering to not just save lives, but to improve the manufacturing and delivery of critical health solutions. Yes, as our name implies, we are working to crack some of the toughest scientific and engineering nuts out there. If you are driven to discover, create, and inspire something that moves science and technology forward, and lasts a lifetime and beyond, you’re ready to be a Nutcracker.
The Director, Quality Assurance, will be an integral part of the team responsible for building and optimizing phase-appropriate Quality Assurance (QA), Quality Systems (QS), and Qualification & Validation (Q&V) programs in support of advancing therapeutic candidates using our novel microfluidic based manufacturing systems (NMU – Nutcracker Manufacturing Unit). This role will be a quality culture champion by providing guidance and oversight to cross-functional teams, and through contributing to innovative, streamlined, and compliance-driven operations. The incumbent will apply their strong cGMP experience, foster open communication, and pursue data-driven as well as risk-based approaches.
Responsibilities:
- Build and optimize phase-appropriate Quality Assurance, Quality Systems, and Qualification & Validation programs.
- Accountable for Training Management, Document Management, Quality Management, Change Control, Deviation, CAPA, Batch Release, Supplier Quality Management, Internal Audit, Complaints, Quality Metrics, and Quality Management Review systems and procedures.
- Build and lead the QA and Q&V teams to achieve business objectives and support IND and facility start up timelines.
- Provide QA guidance and support to manufacturing operations and supporting functions.
- Collaborate cross functionally to establish a quality culture and drive a quality mindset across the organization.
- Apply a risk-based, data-driven, and continuous improvement mindset in support of compliance and process optimization opportunities.
- Cultivate strong, credible relationships with health authorities as well as strategic partners to support business objectives.
Requirements:
- A Minimum of 10 years experience in cGMP environments in pharmaceutical, biotech, or related industry.
- Demonstrated success building and leading a QA team in support of qualification, facility start-up, and production activities.
- Strong expertise in operational cGMP compliance, applicable CMC regulatory requirements, industry trends, and good documentation practices.
- Experienced with qualification & validation of equipment as well as electronic systems for quality and data management. Implementation experience a plus.
- Technical acumen with respect to the areas of manufacturing, quality control, supply chain, process development, and regulatory considerations.
- Outstanding interpersonal, communication and negotiation skills necessary to build strong, cross-functional internal relationships within a highly collaborative team, as well as external stakeholders.
- Develop an organization that strives for quality excellence with emphasis on right first time, optimizing compliant processes, reducing risk, continuous improvement, and management oversight.
- Outstanding problem-solving and analytical skills coupled with maturity, confidence, and strong emotional intelligence.
- An unwavering commitment to safety, ethics, integrity, and building a quality culture.
- A bachelor’s degree in biology, chemistry, or engineering, or another relevant field.
$184,000 - $240,000 a year
The expected salary range for this role is based on candidate experience, education, location, and other job-related factors. Employees are also eligible to participate in benefits including Medical, Dental, Vision, Life Insurance, 401(k), PTO plan and employee stock options.
Nutcracker Therapeutics is an early stage life science company building a workplace where highly collaborative and diverse teams thrive. If your best work is performed in a fast-paced entrepreneurial work environment where meaningful work is mastered each day, we’d love to hear from you.
Nutcracker Therapeutics is an equal opportunity employer and values diversity, as such, we do not unlawfully discriminate on the basis of race, color, religion, citizenship, political activity or affiliation, marital status, age, national origin, ancestry, physical or mental disability, medical condition (as defined under California law), veteran status, sexual orientation, gender identity, gender expression, sex or gender (which includes pregnancy, childbirth, breastfeeding, or related medical conditions), taking or requesting statutorily protected leave, or any other basis protected by law.
