Helaina is a VC-backed biotech startup creating a new category of functional food products.

Our vision is to bring the functional properties of human proteins to food. Helaina will be the first company to put human milk proteins into food, defining a new category of consumer nutrition products focused on supporting immunity. We will initially launch a first-of-its-kind infant formula – the only infant formula with immune-nourishing proteins found in human milk. We also see a range of opportunities to use our breast milk proteins to enhance other types of functional foods for all segments of the population.

Helaina is backed by top VCs in the industry including Spark Capital, Siam Capital, Primary Venture Partners, and Plum Alley. We are a team of change-makers looking for our next team member who is intensely passionate about advancing synthetic biology for food and beverage products and redefining the future of nutrition.

About the Team:

Our vision is to bring the functional properties of human milk proteins to food. The Quality Assurance Director at Helaina has a unique opportunity to build a best-in-class quality assurance program at an early-stage startup. This is a high-impact role that will interface with all other cross-functional heads including Regulatory and R&D to scale up and launch the first recombinant human milk protein. Helaina will be the first company to put human milk proteins into food, defining a new category of consumer nutrition products focused on supporting immunity.

About the Job:

As the Quality Assurance Director you will work as part of a cross-functional team to deliver on business objectives and timelines. You serve a critical role to ensure Helaina has a best-in-class quality management system and meets all US FSMA regulations. You will be key to setting the quality standards for novel protein manufacturing via precision fermentation, qualifying manufacturing partners, and qualifying ingredients for product development.

What You'll Do:

• Ensure compliance to all FSMA related requirements particularly for foreign supplier verification system.
• Manage QA issues related to commodities and assist as necessary for resolution.
• Coordinate external site qualifications and audits.
• Develop and manage annual audit plans for active contract manufacturing sites.
• Develop and maintain Quality System procedures.
• Create internal quality SOPs.
• Drive best-in-class performance in supplier controls and supplier quality improvements.
• Manage execution of site Food Safety Quality Program and HACCP programs. 
• Provide strategic direction and oversight for ingredient and product initiatives to assure continuity of commercial manufacturing by qualifying new commodities and managing current supply to support capacity availability, prevent downtime due to quality related issues, and avoid on market events with safety and reputational impact
• Create an allergen control program and sanitation program.
• Ensure quality infrastructure and standards are in place and maintained at global suppliers to meet compliance requirements for ingredient and product manufacturing sites.
• Plan, define, and direct the site auditing control program to ensure compliance to all procedures and policies to ensure compliance to regulatory federal and local laws.
• Provide recommendations for compliance to minimize audit and product liability, and develop and issue quality reports related to quality or regulatory issues.
• Approve Quality Agreements for high-risk suppliers and set Helaina expectations with suppliers.
• Make determinations on critical matters such as product safety, quality, compliance and regulatory issues related to suppliers and has direct interface with key management for global manufacturing, operations, R&D and regulatory.
  
  

About You:

• You have a Bachelor's Degree or Master's Degree in a Technical field.
• You have at least five years of relevant experience in Quality Assurance and/or Manufacturing.
• You have experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainties.
• You are proficient in organizing and presenting complex technical information to upper-level management.
• You are able to communicate well and decide how information needs to be shared with outside agencies.
• You have a broad understanding of quality principles as well as the technical aspects of ingredient, product, package, process, design, compliance, and manufacture
• You have experience qualifying third party manufacturing sites and/or experience with precision fermentation
  
  

This is a part-time consulting role and compensation is market-competitive with an hourly rate of $70-$85 per hour.

Benefits:

Helaina was founded on the belief that families should have freedom of choice. We are committed to providing an inclusive workplace that does just that, supporting our team's health, wellbeing and professional development at every stage and milestone. We are proud to offer comprehensive health care, generous parental leave and childcare reimbursement, equity packages and more to our Full-Time employees. A few highlights include:

• Full medical, vision and dental coverage
• Short and long term disability insurance coverage
• 401k match (up to 3%)
• Unlimited vacation days, including an all-company holiday between Christmas and New Year
• Paid Parental Leave for both parents + flexible return to work program
• Childcare reimbursement program
• Commuter Benefits
• Leadership Development coaching through BetterUp
  
  

Helaina is an Equal Opportunity Employer. Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Helaina we are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may just be the strongest candidate for this or other roles. For more information, please contact careers@myhelaina.com.

Learn more about Helaina: https://www.myhelaina.com/press