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Product Quality Lead

South San Francisco, California, United States, Princeton, New Jersey, United States

About Us 

Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is our mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve. 

At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   

These values are the foundation of our work, empowering us to make a real difference, every day.  

 

Position Title: Product Quality Lead

Department: Quality & Compliance

Reports To: VP, CMC Quality

 

Job Overview

Kardigan is seeking a Product Quality Leader (PQL) to support the company’s growth toward becoming a global, multi-product commercial-stage biopharmaceutical company. As a PQL, you will ensure the right end-to-end quality plan is developed to support rapid and robust supply to patients in a compliant manner. You will be accountable for all Quality aspects throughout the lifecycle for individual products across our portfolio. Scope of responsibilities covers critical raw materials (where applicable), drug substance, intermediates, drug products, finished labeled drug product, stability, and method validation / transfer activities and includes pre-clinical/clinical FIH stage through pivotal clinical trials and commercial filing, approval, and launch. This position will report to the Vice President, CMC Quality.

 

Essential Duties and Responsibilities

  • Develop end-to-end product quality strategic plan for designated products with clear ownership for each deliverable with Process Development, Analytical Development, Quality Control, Supply Chain, Regulatory and CMC Leaders
  • Collaborate with cross-functional teams such as CMC Regulatory Affairs, Drug Development, Research, and Supply Chain to ensure timely achievement of project milestones and objectives, providing options and contingencies to overcome technical challenges, timeline limitations, or changes to program goals.
  • Work in partnership with CMC Lead, Manufacturing, Quality Control, Process Development, Analytical Development, and Supply Chain to ensure Product Quality standards are met and in compliance with applicable regulatory requirements
  • Ensure impact to product quality is thoroughly assessed during development, routine manufacturing, and distribution of drug product, including escalating quality and compliance issues
  • Provide succinct and pertinent communication of CMC status, priorities and pending activities from a Quality perspective across company functional areas and to senior leadership
  • Provide expert quality guidance related to relevant quality guidelines, regulations and expectations
  • Support creation and/or review of CMC sections of regulatory submissions (i.e. IMPD/INDs/NDA), and responses to regulatory agency correspondence (i.e., FDA, EMA, etc.)
  • Assess and provide decisions with respect to relevant change controls, deviations, investigations, CAPAs and complaints
  • As needed, perform batch disposition and release activities
  • Provide Quality oversight of activities such as process validation, ongoing process verification, tech transfer, etc.
  • Assist in the selection of contract organizations, ensuring the effective outsourcing and execution of Quality activities. This includes ensuring appropriate Quality Agreements are in place and assisting in periodic audits of CDMOs as needed.
  • Develop strong relationships with external CDMO partners to establish and ensure all activities are within program expectations, including maintaining metrics for partner adherence to Quality Agreements.
  • Lead development of product-specific Quality Risk Assessments
  • Promote a culture of continuous improvement, quality mindset, and cross-functional problem-solving
  • Maintain flexibility to perform other functional or company-wide or industry-related activities or projects as assigned

 

Qualifications and Preferred Skills

  • Bachelor’s and/or an advanced degree in a life science with at least 15 years of experience in pharmaceutical and/or biologics industry with solid experience in lifecycle management of products, tech transfer, process validation and launches.
    • Experience in product / process development, analytical development and / or CMC team leadership strongly preferred.
  • Successful track record in leading Quality-related CMC activities from research to clinical studies to registration
  • Strong knowledge of CMC and Quality requirements, including thorough understanding of ICH, FDA, and EMA guidance and GMP requirements governing product/process development, manufacturing, testing (including stability) and distribution.
  • Experience in authoring, reviewing / approving and providing technical support to regulatory filings (IND/IMPD/MAA/BLA, etc.)
  • Technical expertise in analytical process, product characterization and stability strongly preferred
  • Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions
  • Demonstrated project management skills with respect to planning / tracking, prioritizing and adhering to project timelines.
  • Proven track record of establishing excellent relationships and partnerships across Tech Ops and R&D organizations to proactively build compliance into standard practices and mindset
  • Collaborate and communicate with all levels of employees, including peers, executives and cross-functionally
  • Demonstrated ability to work effectively in a fast-paced, team-oriented environment
  • Excellent communication skills (interpersonal, written and verbal), and leadership skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)

 

Exact Compensation may vary based on skills, experience and location.

Pay range

$244,000 - $318,000 USD

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