Director / Associate Director, Quality Assurance

The Opportunity

• Do you love quality systems, making sure we stay compliant and can speak GLP, GCP and GMP fluently? We are continuing to build out our pharmaceutical development teams and need our very first person to build out Quality Assurance.
• In this brand-new role, you will take the lead on establishing phase appropriate quality systems to maintain compliance with applicable regulatory standards
• Quality is critical across all functions and we are looking for a creative and detail-oriented person who will create flexible systems that foster inter-departmental collaboration.

Your Role

• You will implement and manage the systems and procedures that ensure compliance with applicable regulations (GLP, cGMP, GCP)
• We will rely on you to ensure that Relay Tx procedures are consistent with clinical, manufacturing and stage appropriate development activities
• We need your help drafting and implementing appropriate Standard Operating Procedures
• Effectively develop and maintain audit programs to satisfy contractual and regulatory requirements
• You will coordinate and/or conduct audits (internal and external) and routine QA inspections with the help of external quality consultants/auditors
• We know you are the expert so we will look to you to establish GCP, GMP and GLP training programs
• Last but not least, you will participate in regulatory agency inspections

Your Background

• You earned a Bachelor’s degree in life sciences or related field
  
• You have 7-10 years of experience in a quality function, with at least 3 in a management capacity
• This isn’t your first rodeo, as you have had prior experience in pharmaceutical drug development
• It is important that you have demonstrated the ability to lead operational teams and appropriately interface with technical/scientific teammates
  
• Your former coworkers describe you as a self-motivated decision maker with ability to escalate appropriately
• Things move quickly here; you thrive in a fast-paced environment. No one will stop you or hold you back, we’ll give you the tools and resources to push forward relentlessly
• Do you have an eagle eye for quality? Especially critical review, interpretation and implementation of guidance documents are your strengths. We’ll depend on you to ensure proper internal standards are implemented to assure compliance is maintained
• You are an open and articulate communicator who can collaborate with clinical vendors, contract laboratories and manufacturing facilities and internal staff.
  
• Equally important, you’re known to build strong relationships with external quality consultants and vendors to assure clinical trial conduct under GCP, GLP compliance of bioanalysis & key toxicology studies and the appropriate release of cGMP drug product

We believe in building balanced teams and a place where our people can be their best self every day. We encourage people from underrepresented backgrounds to apply.

Relay Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Our Culture:
At Relay Tx, we believe that along with our people, our culture is our greatest asset. In fact we're proud to share we were named as one of the Boston Business Journal's "Best Places to Work" in 2017, the #1 place for small companies in 2018 & the #2 place for small companies in 2019. To drive that culture, no one will stop you or hold you back. Instead, we will give you the tools and colleagues to push forward relentlessly and cheer you on as you go. If this resonates with you, drop us a line.

About Relay Therapeutics
Relay Therapeutics is a new breed of company at the intersection of computation and biotechnology that is committed to creating medicines that will have a transformative impact on patients.

We combine unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry, and biology. This integration illuminates – for the first time – the full mobility of a protein and provides key insights into how the dynamic nature of a protein’s conformation regulates function. The team at Relay is putting this principle into practice, with the aim of accelerating the development of medicines that will make a transformative difference in patients’ lives. We don't just stare hard problems in the face. We go out looking for them. Are you energized by attempting to do the impossible? We're looking for you.

At Relay, our team is driven by the ultimate collaboration across each of our drug discovery disciplines. Putting protein motion at the heart of drug discovery is a challenge, but we are confident that our team’s dedication and urgency will create opportunities that deeply impact the lives of the patients. Our initial programs are focused on developing therapeutics in oncology.

Relay Therapeutics is a public company launched in 2016 with financing from Third Rock Ventures and an affiliate of D. E. Shaw Research.