Associate Director, Quality Management System

Job Title: Associate Director, QMS

Location: Hybrid – Waltham, MA. Open to remote for non-local candidates.

Role Overview:

The Associate Director, Quality Management System, will report to the Director, Quality Systems. You will be responsible for providing quality oversight for Oruka’s quality management system, Veeva, document control oversight, training program management and eQMS administration. You have a strong background in Quality Systems and developing processes for clinical stage biopharmaceutical companies.  Model high standards for integrity, collaboration, and accountability while being comfortable making risk-based decisions and executing with discipline in ambiguous situations. You are a hands-on, natural self-starter with strong organizational skills who thrives in a dynamic, fast-paced environment, and communicate effectively with colleagues, executive leaders, external partners, and customers.

Key Responsibilities:

Primary owner of QMS infrastructure and electronic systems

Responsibilities

• 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.

Qualifications:

Required

• 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.

Preferred

• Experience supporting the onboarding and oversight of electronic GMP systems.
• Prior experience contributing to the build-out or enhancement of a QMS in a development-stage company.
• Experience with visual management dashboards (Excel/Smartsheet).
• Prior involvement in supporting regulatory inspections and authoring/reviewing regulatory submissions.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates who will work in Waltham,MA is $182,000 - $208,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer, and this salary range may not reflect positions that work in other states.

Job Location:

• Hybrid – Waltham, MA. Open to remote for non-local candidates.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.