Manager/Senior Manager, Quality Assurance

Your Impact

Alpha-9 Oncology is seeking a highly motivated Manager/Senior Manager, Quality Assurance with a strong GMP background to join our growing team. As a clinical-stage biotech focused on radiopharmaceutical innovation, we are looking for a hands-on quality professional who thrives in a small, dynamic environment and can support batch release for early-stage clinical programs.

Reporting to the Senior Director, Quality Assurance, you will play a key role in maintaining our GMP quality processes, ensuring compliance with regulatory requirements, and supporting clinical-stage manufacturing activities. This role will require strong collaboration with CDMOs and external partners to ensure quality standards are upheld. This role provides visibility and opportunities to professionally grow in the GxP QA area in addition to the primary responsibilities.

How You'll Contribute

• Serve as the QA subject matter expert for all CMC-related quality activities and collaborate with the CMC team on investigational product manufacturing/packaging and release, stability program, change management, vendor selection and GMP related audits.
• Collaborate cross-functionally with CMC, clinical supply,  external manufacturing partners, analytical, and regulatory teams to ensure appropriate QA oversight for contract manufacturing, packaging/labeling and testing.
• Support internal and external audits, including vendor qualification and regulatory inspections.
• Support establishing and maintaining a ‘fit for purpose’ QA approach to GMP documentation such as SOPs, quality documentation, and GMP records.
• Assist in training programs to foster a quality-driven culture across the organization.
• Work closely with CDMOs and external partners to review documents and quality events to support clinical product manufacturing and testing.
• Identify process improvement opportunities to enhance efficiency and compliance within the QA function.
• Support CMC with metrics and trend review for ongoing just-in-time manufacturing activities.
• Support the development and maintenance of the quality management system including but not limited to document management system, training, SOP development , Deviation and CAPA management.

The Skills You Bring

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field.
• 5+ years of experience in a GMP Quality Assurance role within biotech or pharmaceutical manufacturing (early-stage clinical experience preferred).
• Prior experience with radiopharmaceutical or other just-in-time manufacturing platforms is a plus.
• Strategic and creative thinker, independent strong leader, and subject matter expert in cGMPS and a passion for driving a quality mindset across the organization.
• Strong understanding of GMP regulations (FDA, EMA, ICH) and clinical-stage quality processes.
• Experience with batch record review, release, and deviation investigations.
• Experience working with CDMOs and external manufacturing partners.
• Strong problem-solving skills and the ability to work independently in a fast-paced environment.
• Effective communicator with a collaborative mindset and ability to work cross-functionally.

What's in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.