Manager, Quality Systems

Manager, Quality Systems

Cambridge or Remote

As a member of the Parabilis Medicines team, you will be a part of an organization dedicated to creating extraordinary medicines for diseases with urgent unmet needs, harnessing our proprietary peptide platform to transform treatment possibilities for patients. Parabilis is a clinical-stage biopharmaceutical company dedicated to unlocking high-impact protein targets long-considered undruggable. The company has developed a new class of stabilized, cell-penetrant alpha-helical peptides – Helicons™ – capable of modulating intracellular proteins that are inaccessible to traditional drug modalities.

Headquartered in Cambridge, Mass., Parabilis is advancing a focused pipeline of multiple first-in-class therapies across both rare and common cancers. Its lead asset, zolucatetide (FOG-001), is a first-in-class, clinically validated direct inhibitor of the interaction between β-catenin and the T-cell factor (TCF) family of transcription factors, implicated in millions of cancer cases annually, including in colorectal cancer, desmoid tumors, hepatocellular carcinoma and a range of other Wnt/β-catenin-driven tumors. In Phase 1 clinical trials, zolucatetide produced the first-ever clinical evidence that it can directly inhibit this interaction, once previously considered "undruggable" despite its role across multiple cancer types. Parabilis is also advancing investigational degraders of ERG and ARON into clinical development for the treatment of prostate cancer, as well as progressing other preclinical programs. Backed by a recent $305 million Series F financing, Parabilis is entering an exciting phase of growth and execution.

The Quality Systems Manager at Parabilis Medicines is responsible for implementing and maintaining the company's quality management system (QMS) to ensure compliance with regulatory requirements (e.g. FDA, EMA, ICH, etc.) and internal standards. The role sits at the center of compliance, operations and continuous improvement and is a vital partner for all GxP functions in the organization.

Key responsibilities:

• Manage core quality management system (QMS) elements
• Document control: Manage the lifecycle of GxP documents to ensure compliance with regulations and internal procedures. This includes but is not limited to formatting, routing workflows, managing metadata, reviewing, approving and making documents effective.
• Quality events: Manage workflows related to CAPAs (Corrective and Preventive Actions), Change Controls and Deviations and Investigations.
• Inspection readiness: Support all inspection readiness initiatives including but not limited to self-inspections and regulatory inspections.
• Management review: Support the tracking and reporting of quality KPIs (e.g., deviation closure time, audit findings, etc.) and assist in the preparation of slides, meeting coordination and presentation of quality trends to senior leadership.
• Supplier management: Support qualification and approval activities of external suppliers.
• Training administration: Manage training requirements, curricula and learner roles in the company Learning Management System (LMS). Collaborate with process owners to ensure that procedures and other training material are assigned appropriately. Provide training metrics to assist in on time training completion.

What you'll need to be successful:

• Minimum education: Bachelor's degree in life sciences or equivalent
• 6+ years of industry experience with hands-on quality systems work and knowledge of regulatory requirements across various compliance categories (GMP, GCP, etc.).
• Specific qualifications: Proficient in Veeva electronic Quality Management System including documentation, quality events and training.
• Skilled in data integrity principles.
• Demonstrated ability to utilize AI tools for day-to-day work; baseline proficiency is expected, and advanced or innovative use of AI is a strong plus
• Remote but able to attend in-person meetings if applicable.

Core values:

• Growth-Minded . We're inventing a new class of medicines—one applicable to therapeutic targets that have been dreamt about, but always considered impossible to drug. Our work requires us to be curious, humble and adaptable.
• In(ter)dependent . We are fiercely independent as a leader in defying the limitations of current therapeutic modalities, and interdependent as a team as we work collaboratively to shift drug discovery paradigms and provide patients with better treatment options.
• Patient-focused . We are deeply focused on patient outcomes, and all energy in the company is focused on science as it translates to patient impact.
• All-In . We're All-In on solving some of the hardest scientific challenges and delivering one of the most effective new classes of drugs in history.

The base salary range for this position is $125,000-$155,000 per year, depending on experience, qualifications, and internal practices. Parabilis's total compensation package also includes an annual target bonus, equity, and a comprehensive suite of competitive benefits designed to support our employees' overall well-being.

As an equal opportunity employer, Parabilis Medicines values an inclusive workplace and welcomes applicants of all backgrounds and experiences. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.