Associate Director, Quality Management System

Oruka Therapeutics

Associate Director, Quality Management System overseeing QMS processes and compliance in clinical biopharmaceuticals. Leading quality initiatives and managing training programs for Oruka Therapeutics.

Posted 4/24/2026full-timeWaltham • Massachusetts • 🇺🇸 United StatesSenior💰 $182,000 - $208,000 per yearWebsite

About the role

Key responsibilities & impact

Primary owner of QMS infrastructure and electronic systems.
Provide oversight of document control processes, including creation, review, approval, and lifecycle management of policies, SOPs, and forms.
Manage training program, including creation, assignment, and tracking of training; onboarding and GMP refresher training; and maintenance of training curricula.
Administer the electronic Quality Management System (eQMS), including system implementation, validation, and management of periodic releases.
Oversee the deviation process for compliance, ensuring appropriate documentation and adherence to procedures.
Review and oversee CAPAs to ensure process compliance and effectiveness of corrective and preventive actions.
Administer change control system and manage departmental changes.
Coordinate product complaint processing.
Review and approve GMP documentation, as requested.
Review and support GMP investigations related to deviations, ensuring appropriate root cause analysis and CAPA development and implementation.
Assist with the development, tracking, and reporting of GMP quality metrics and KPIs; identify trends and support continuous improvement initiatives.
Support inspection readiness activities for both Oruka and its GMP suppliers.
Escalate quality risks and compliance issues appropriately and support risk-based decision making.
Promote a culture of quality and continuous improvement across the organization.
Approximately 15–20% travel (domestic and international) to GMP suppliers and Oruka offices.

Requirements

What you’ll need

Bachelor’s degree in a scientific field with a minimum of 8 years of experience in GMP Quality or Manufacturing in a biotechnology or pharmaceutical setting; experience in biologics is required.
In depth knowledge of cGMP, FDA/EMA regulations, and applicable guidelines (e.g., ICH, WHO).
Experience supporting early phase clinical through commercial manufacturing, including the use of contract manufacturers.
Strong analytical, investigative, and problem-solving skills, with the ability to design creative solutions to complex challenges.
Excellent interpersonal and communication skills, with a strong team orientation and an ability to mentor and develop junior staff.
Ability to work in a fast-paced, ever-changing environment, prioritizing and managing multiple tasks simultaneously.
Able to travel domestically and internationally.

Benefits

Comp & perks

Competitive salary and benefits package.
A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
Opportunities for professional growth and development.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

QMS infrastructuredocument control processeseQMS administrationGMP documentation reviewCAPA developmentchange control system managementGMP quality metricsroot cause analysiscompliance oversighttraining program management

Soft Skills

analytical skillsinvestigative skillsproblem-solving skillsinterpersonal skillscommunication skillsteam orientationmentoringprioritizationmultitaskingadaptability