The Role:

The Quality Professional II will manage the Quality Systems, Audit and Compliance program and be responsible for the Self-inspection/Internal Audit and coordination of the External Audit processes, to ensure all ElevateBio’s processes and systems are in compliance with internal policies and procedures, as well as applicable US and international regulations, laws, and guidelines.

Here’s What You’ll Do:

Under the guidance of the Director of Quality Systems, the candidate will:

Internal Audit (self-inspection):

• Manage and execute the internal audit strategy and schedule with cross-functional team, including Quality and Site leadership
• Lead and/or coordinate the planning, execution, risk mitigation and close out of internal audits
• Collaborate with and coach internal auditees and Quality partners for internal audit observations; ensure auditees deliver appropriate CAPAs and monitor through to closure.
• Ensure that audit results are timely, constructively written, and formally recorded and reported with corrective and preventive actions documented appropriately.
• Monitor, update and report on internal audit program metrics
• Train, coach and develop co-auditors and subject matter experts to support the audit program

External Audit:

• Liaise with Supplier Quality Program stakeholders to coordinate and prioritize the completion of external audits
• Lead and/or support the planning, execution, risk mitigation and close out of planned external audits or assessments, including working with and coordinating contracted auditors and audit records.
• Communicate with and monitor external supplier compliance to audits, quality agreements, and corrective actions
• Monitor, update and report on external audit program metrics
• Travel may be up to 50% during periods throughout the year to support external auditing activities
•  

Additionally, will be responsible to:

• Support hosting client audits and regulatory health authority inspections
• Compile and provide operational and quality metrics for periodic Management review.
• Promote a Quality Culture by driving continuous improvement, innovation, teamwork and efficiency.

Requirements:

• BS in a scientific or engineering discipline with minimum of 8 years of experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility, with at least 2 years conducting internal and external audits.
• Auditor certification highly preferred
• Experience in cell and gene therapy or advanced therapies pharmaceutical industry preferred
• Experience in CDMO setting preferred
• Knowledge of domestic and international GMP and pharmaceutical regulations
• Ability to communicate effectively and work independently with scientific/technical personnel.
• Strong knowledge of GMP, SOPs, and quality system processes
• Outstanding communication skills (verbal and written)
• Ability to manage multiple projects in a fast-paced environment
• Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.
• Has advanced understanding of the job and applies knowledge and skills to complete a wide range of tasks. Familiar with a variety of the field’s concepts, practices, and procedures
• Requires thorough knowledge of the department and company operations, policies and procedures
• High degree of independence. Requires very limited supervision when acting or making decisions within existing policies and practices. Relies on experience and judgment to plan and accomplish goal