Head of Quality Assurance

1 day ago

South San Francisco, California, United States Abdera Therapeutics Full time
Who we are
Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively destroy tumor cells while sparing healthy cells. Abdera is using this platform to enable the rapid development of a broad range of safe and efficacious therapies serving cancer patients with limited treatment options.
Abdera Therapeutics is growing rapidly and seeking key new team members who thrive at the cutting-edge of innovation. Come join us and be a part of the ground-breaking team set to unlock the power of targeted radiotherapy
What we look for
At Abdera Therapeutics, we are looking for curious and committed individuals who are ready for the opportunity to transform the way people living with cancer can be treated. We are devoted to advancing novel treatment options that offer new hope to families facing devastating diagnoses. We are in search of team members who work collaboratively with a diverse group of colleagues, respectfully engaging one another while collectively and inclusively tackling any challenges we may face. We are building an exciting and fast paced company passionate about discovering and developing tomorrow's most innovative cancer therapies.
Abdera is seeking a Head of Quality Assurance to build and lead the company's quality capabilities. This senior leadership role is responsible for developing, implementing, and executing the company's overall quality strategy, ensuring compliance with GxP regulations across all stages of product development and manufacturing. Key responsibilities include building and leading the quality team and culture, managing the Quality Management System, overseeing quality control and assurance, managing audits, providing cross-functional GMP/GCP/GLP compliance partnership for ongoing and new clinical studies, and acting as the primary quality contact for regulatory agencies and external partners
Strong leadership skills and quality technical background are required. A successful applicant must have prior hands-on early phase quality experience taking a novel cancer therapy through IND and into clinical trials, setting up and maintaining quality management systems, overseeing external GMP contract manufacturing and CRO, and be comfortable in a fast moving and nimble culture.

Salary range:TBD
  Principal Responsibilities
Building Quality Assurance Team and Capabilities
  • Develop and implement a comprehensive quality strategy aligned with business objectives.
  • Lead the QA function, including Supplier Management, Audits, Quality Systems, Document Control, Training, as well as GMP/GCP/GLP compliance.
  • Build, mentor, and lead a high-performing quality team, fostering a culture of accountability and continuous improvement.
  • Provide quality oversight to enable contract manufacturing and clinical trials.
  • Develop and manage quality budget
  • Implementing Quality Management Systems
  • Oversee the development, implementation, and maintenance of the Quality Management Systems including Quality Management Review
  • Implement and integrate risk management strategies throughout the product lifecycle.
  • Identify and mitigate risks associated with quality and compliance associated with product lifecycle.
  • Drive continuous improvement of document control systems and promote adherence to company policies, SOPs, and guidelines.
  • Identify and anticipate trends in quality issues, collaborate with leadership team to implement continuous improvement and quality initiatives
  • Analyze Key Performance Indicators (KPI's) and report status of quality systems to Executive Committee
  • Responsible for internal and external audit preparation, training, and serve as lead FDA/Regulated Authority liaison during audits
  • Supporting CMC programs and Clinical Trials
  • Support clinical trial operations by ensuring all aspects of ICH GCP are followed
  • Provide clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations
  • Provides strategic leadership and direction for clinical quality assurance operations, ensuring compliance with regulatory standards and driving continuous improvement of Good Clinical Practices (GCPs).
  • Provide QA leadership on project teams and contract manufacturers. Direct all aspects of quality support and strategy for the project team on the designated product(s).
  • Provide expertise in the interpretation of regulations and guidance relating to product development from a quality perspective.
  • Actively monitor ongoing contractor-related manufacturing, quality control testing, and other activities. Provide feedback to stakeholders in a timely manner as per established Quality Agreements.
  • Review and approve partner/contractor GLP/GCP/GMP quality agreements and documentation
 Qualifications, Education & Experience
  • Bachelor's degree in chemistry, biochemistry, pharmacy, pharmacology, or related   scientific discipline required.
  • Master's Degree, PharmD or PhD preferred.
  • At least 18 years of Quality Assurance experience in FDA regulated industry
  • Prior experience with FDA submissions including IND and early-stage experience required.
  • Prior expertise in Radiopharmaceutical desired.
  • Competence in FDA, international GMP and GCP requirements.
  • Strong written, verbal, and interpersonal communication skills, with the ability to effectively interact with individuals at all levels across organizations.
  • Experience in leading Quality function in fast paced early clinical stage companies.
Skills and Abilities
  • Builds a learning environment that recognizes the value of each contributor and promotes a solutions-oriented mindset.
  • Ability to constructively challenge, question, and provide creative suggestions for regulatory trial processes to create the most efficient and effective methods to deliver quality clinical trial services.
  • Willingness to collaborate with team to identify and implement best practices for optimizing performance.
  • Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
  • Strong leadership skills in leading team members and vendors.
  • Demonstrated ability to manage and coordinate internal and external resources independent from managerial oversight.
  • Strong organizational, communication and interpersonal skills
  • Ability to prioritize, delegate and execute quality responsibilities and deliverables to meet project deadlines.

At Abdera, we recognize the importance of attracting and retaining the best talent, and we're committed to offering competitive compensation and comprehensive benefits tailored to your needs.
Here's what you can expect when you join our team in the U.S.:
  • Competitive Base Pay: Our expected base pay range for this position is $XXX - $XXX (USD), plus performance-based bonuses.
  • Comprehensive Benefits: Health, Dental, Vision, Prescription drug coverage, Basic Life and AD&D insurance, both Long-Term and Short-Term disability 16 paid company holiday, 20 days of PTO and 6 sick days to ensure your well-being, as well as a 401k plan with up to 3.5% company match, equity and bonus to help secure your financial future.
  • Personalized Pay: Your individual pay will be determined by your job-related skills, experience, and relevant education or training, ensuring you receive fair and competitive compensation.
  • Work-Life Balance: We also offer a hybrid work schedule with 3 days on-site along with development and growth opportunities.
  • At Abdera, we value our employees and strive to create an environment where you can thrive both professionally and personally. Join us and be part of a company that cares about your growth and well-being.
Abdera is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Abdera, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This is applicable to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship.

  • Director of Quality Assurance

    1 day ago

    South San Francisco, California, United States Zenflow Full time $190,000 - $225,000

    About ZenflowZenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal...

  • Quality Assurance and POCT Supervisor

    5 days ago

    San Francisco, California, United States University of California - San Francisco Full time

    The Clinical Laboratory at Zuckerberg San Francisco General provides laboratory testing services for inpatients and outpatients of ZSFG, Laguna Honda Hospital, District Health Centers, and other facilities under the auspices of the SF Public Health Department. Under the general supervision of the Laboratory Administrative Director and Division Directors,...

  • Director of Quality Assurance

    2 days ago

    San Francisco, California, United States Zenflow Full time

    About ZenflowZenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by enlarged prostate. The innovative Spring technology was designed with the patient experience in mind and relies on a small spring-like coil that gently props open the urethra, restoring its normal...

  • Quality Assurance Supervisor

    5 days ago

    San Mateo, California, United States County of San Mateo Full time

    The County of San Mateo's Human Services Agency (HSA) is seeking qualified applicants for the position of Quality Assurance Supervisor (Human Services Supervisor). The vacancy is under the Program Integrity and Community Services (PICS) Branch and will report directly to the Quality Assurance Manager.The Quality Assurance team ensures accurate documentation...

  • Manager, Quality Assurance

    3 days ago

    San Francisco, California, United States DoorDash Full time

    About the TeamCustomer Experience and Integrity (CXI) is at the core of DoorDash's operating engine. As a leader of the CXI Quality Assurance Team, you'll shape the future of the customer experience at DoorDash. Our team influences agents, auditors, and stakeholders across the Support & Integrity organization. We're passionate about delivering an end-to-end...

  • VP Quality Assurance, Infusion

    2 weeks ago

    San Francisco, California, United States BD Full time $228,600 - $411,500

    Job Description SummaryQuality Assurance leader for Infusion products platform, responsible for end to end quality systems, development quality and post market quality of the platform products.Job DescriptionWe are the makers of possible   BD is one of the largest global medical technology companies in the world. Advancing the world of health is our...

  • Senior Director, GMP Quality Assurance

    2 weeks ago

    South San Francisco, California, United States Septerna Full time $265,000 - $285,000

    Septerna is a biotechnology company based in South San Francisco, CA on a mission to develop life-changing medicines for patients with the vision to become the industry-leading G protein-coupled receptor (GPCR)-focused drug discovery company. The company's Native Complex Platform recapitulates GPCRs with their native structure, function, and dynamics outside...

  • Calypso Quality Assurance Lead, Dir

    2 weeks ago

    San Francisco, California, United States Federal Home Loan Bank of San Francisco Full time $170,000 - $190,000 per year

    Job DescriptionPurpose:Acts as a team lead of a Quality Assurance team and supports the QA vision to deliver consistent and value-added testing solutions that align with business needs/goals. Adheres to QA standards, applies QA methodology, develops test strategies, and ensures robust repeatable, maintainable, regression for the Calypso platform....

  • Calypso Quality Assurance Lead, Dir

    6 days ago

    San Francisco, California, United States Federal Home Loan Bank of San Francisco Full time $170,000 - $190,000

    Job Description:Purpose:  Acts as a team lead of a Quality Assurance team and supports the QA vision to deliver consistent and value-added testing solutions that align with business needs/goals. Adheres to QA standards, applies QA methodology, develops test strategies, and ensures robust repeatable, maintainable, regression for the Calypso platform....

  • Lead Quality Assurance Engineer

    2 weeks ago

    San Francisco, California, United States myGwork - LGBTQ+ Business Community Full time $150,000 - $210,000 per year

    This job is with HP, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.Lead Quality Assurance Engineer - HP IQDescription -Who We AreHP IQ is HP's new AI innovation lab. Combining startup agility with HP's global scale, we're building intelligent...