Formation Bio Logo

Formation Bio

Director, Quality Management Systems

Posted 10 Days Ago
Be an Early Applicant
Easy Apply
Hybrid
2 Locations
190K-300K
Senior level
Easy Apply
Hybrid
2 Locations
190K-300K
Senior level
The Director, Quality Management Systems ensures quality compliance in pharmaceutical products by establishing, maintaining, and overseeing a quality management system and leading audits and improvements.
The summary above was generated by AI

About Formation Bio

Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. 

Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to develop programs past clinical proof of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, Sam Altman, John Doerr, Spark Capital, SV Angel Growth, and others. 

You can read more at the following links:

  • Our Vision for AI in Pharma
  • Our Current Drug Portfolio
  • Our Technology & Platform

At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more efficiently.

About the Position

The Director, Quality Management Systems plays a pivotal role in ensuring quality, safety, and efficacy of pharmaceutical products through the establishment and continuous improvement of an effective, compliant and ‘fit for purpose’ quality management system (QMS) ensuring Formation Bio is in a phase appropriate, inspection ready state. This role is responsible for overseeing all aspects of the quality system, including the development, implementation, and maintenance of quality systems to ensure adherence to regulatory requirements, industry standards, and best practices in pharmaceutical manufacturing and defending it during health authority audits.

Responsibilities

  • Develop, implement, and maintain the pharmaceutical quality management system (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA), industry standards (e.g., cGMP), and company policies.
  • Establish and maintain quality assurance procedures, processes, and documentation to ensure the consistent production of safe, effective, and high-quality pharmaceutical products.
  • Lead internal and external audits to assess compliance with regulatory requirements, identify areas for improvement, and implement corrective and preventive actions (CAPAs) as needed.
  • Collaborate with cross-functional teams (e.g., Engineering, Tech, R&D, Manufacturing, Regulatory Affairs) to ensure alignment on quality objectives, initiatives, and priorities.
  • Develop and implement quality metrics, key performance indicators (KPIs), and dashboards to monitor the QMS's performance and drive continuous improvement.
  • In collaboration with GXP Quality Leads, ensure the timely investigation and resolution of deviations, non-conformities, and customer complaints related to product quality, safety, or efficacy.
  • Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the QMS.
  • Provide leadership, mentorship, and coaching to the quality system team, fostering a culture of quality excellence, accountability, and continuous learning.
  • Serve as a subject matter expert on quality assurance matters during regulatory inspections, customer audits, and internal reviews, ensuring successful outcomes and compliance with requirements.

About You

  • Strategic and creative thinker, strong leader, and subject matter expert in pharmaceutical quality systems with the ability to design and implement a ‘fit for purpose’ Quality Management System and a passion for driving a quality mindset across the organization.
  • Curious about AI technologies and interested in exploring ways of applying them to the Quality function.
  • Bachelor’s degree in pharmacy, pharmaceutical sciences, chemistry, or a related scientific discipline. Advanced degree (e.g., Master's or PhD) is preferred.
  • Extensive experience (+12 years) in quality assurance roles within the pharmaceutical industry, with a strong understanding of cGMP regulations, quality systems, and pharmaceutical manufacturing processes. 
  • In-depth knowledge of regulatory requirements and guidelines governing pharmaceutical quality assurance, including FDA regulations and ICH guidelines.
  • Proven experience in developing, implementing, and managing pharmaceutical quality management systems, including document control, training management, change control, corrective action preventative action, and deviation management processes.
  • Strong leadership and communication skills, with the ability to effectively collaborate, influence and educate stakeholders at all levels of the organization.
  • Experience leading regulatory inspections (e.g., FDA inspections, MHRA inspections, EMA inspections, etc.) and customer audits, with a track record of successful outcomes.
  • Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance.
  • Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively.
  • Proficiency in quality management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and quality management software systems.
  • Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment.


Compensation:

Salary ranges are informed in part by geographic location, in addition to other factors. The target salary ranges for this role are: 

  • NYC Metro Area, Boston Metro Area, SF Bay Area: $210,000 - $300,000
  • All Other Eligible Remote Locations: $190,000 - $270,000

The ranges provided above include base salary only. In addition to base salary, we offer equity, generous perks, hybrid flexibility, and comprehensive benefits.

If this range doesn’t match your expectations, please still apply because we may have something else for you.

**Eligible Remote Locations:
Alabama (AL), Arizona (AZ), California (CA), Connecticut (CT), Florida (FL), Georgia (GA), Illinois (IL), Indiana (IN), Maryland (MD), Massachusetts (MA), New Hampshire (NH), New Jersey (NJ), North Carolina (NC), Ohio (OH), Pennsylvania (PA), South Carolina (SC), Texas (TX), Utah (UT), Virginia (VA), and Washington, D.C. (DC).

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

#LI-hybrid

Top Skills

Cgmp
Quality Assurance Tools
Quality Management Software
Quality Management Systems
Regulatory Requirements

Similar Jobs at Formation Bio

8 Hours Ago
Easy Apply
Hybrid
2 Locations
Easy Apply
285K-372K
Expert/Leader
285K-372K
Expert/Leader
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
Lead deal structuring and negotiations for M&A and venture financing, ensuring strategic alignment and financial soundness. Collaborate cross-functionally to streamline execution and stay aware of market dynamics.
Top Skills: AIBiotechDrug DevelopmentFinancePharma
Yesterday
Easy Apply
Hybrid
New York, NY, USA
Easy Apply
238K-300K
Senior level
238K-300K
Senior level
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
The Director of Medical Writing will develop and implement medical writing strategies to support clinical development activities, manage document creation, and ensure compliance with regulatory guidelines.
Top Skills: AIDrug Discovery AutomationGenerative Ai Tools
8 Days Ago
Easy Apply
Hybrid
New York, NY, USA
Easy Apply
190K-250K
Senior level
190K-250K
Senior level
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
The Director of Clinical Project Management leads clinical project management functions, ensuring compliance, budget adherence, and efficient execution of multiple clinical trials, while promoting AI integration in drug development.
Top Skills: Ai TechnologyClinical Trial Management Systems

What you need to know about the Boston Tech Scene

Boston is a powerhouse for technology innovation thanks to world-class research universities like MIT and Harvard and a robust pipeline of venture capital investment. Host to the first telephone call and one of the first general-purpose computers ever put into use, Boston is now a hub for biotechnology, robotics and artificial intelligence — though it’s also home to several B2B software giants. So it’s no surprise that the city consistently ranks among the greatest startup ecosystems in the world.

Key Facts About Boston Tech

  • Number of Tech Workers: 269,000; 9.4% of overall workforce (2024 CompTIA survey)
  • Major Tech Employers: Thermo Fisher Scientific, Toast, Klaviyo, HubSpot, DraftKings
  • Key Industries: Artificial intelligence, biotechnology, robotics, software, aerospace
  • Funding Landscape: $15.7 billion in venture capital funding in 2024 (Pitchbook)
  • Notable Investors: Summit Partners, Volition Capital, Bain Capital Ventures, MassVentures, Highland Capital Partners
  • Research Centers and Universities: MIT, Harvard University, Boston College, Tufts University, Boston University, Northeastern University, Smithsonian Astrophysical Observatory, National Bureau of Economic Research, Broad Institute, Lowell Center for Space Science & Technology, National Emerging Infectious Diseases Laboratories

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account