• Lead an organizational structure to include Regional Quality Directors responsible for the Quality Assurance team in each plasma center.
• Establish Quality Systems, policies, initiatives, and structures that support the organization’s global quality reputation.
• Develop the quality strategic plans and establish overall departmental goals to support company objectives.
• Develops quality processes and strategies to ensure compliance with all regulatory agencies and improves internal quality practices.
• Research U.S. and EU regulations to provide current interpretation of requirements to ensure products manufactured, tested, processed, stored, and distributed are compliant.
• Develop and implement robust tracking and trending process that provides information to the organization to improve overall quality processes.
• Execute Quality plans for the organization and leads large, complex project initiatives that may have both local and global impact.
• Interfaces with regulatory agencies, customers, and vendors as required and participates in regulatory authority inspections.
• Serves as the Field Quality representative to the Change Control Board to assess the regulatory and compliance impact of changes.
• Oversee formal risk assessments, investigations and determine downs stream impact and need for escalation and regulatory reporting.
• Evaluate data trends against regulatory and customer requirements to identify opportunities to reduce waste/ costs, improve production, and/or optimize a process.
• Provide cross training and development opportunities, mentor/coach Field Quality team members.

• Bachelor’s degree in life sciences or related field required. Other combinations of education and experience may be considered.
• Five (5) years’ job-related experience in a Biologics, drug manufacturing, medical device facility or FDA regulated environment required.
• Five (5) years’ experience leading people required. Remote management experience preferred.
• Demonstrated knowledge of cGMPs, FDA regulations, and SOP implementations and an understanding of Quality Assurance principles and auditing functions required.
• Strong organizational skills and attention to detail required.
• Excellent verbal, written, and interpersonal communication skills required.
• Demonstrated decision-making ability required.
• Proven skills in data analysis required.

Physical Requirements:

• Ability to sit for extended periods of time
• Ability to use a computer and other office equipment
• Ability to occasionally lift and carry up to 20 pounds
• Ability to reach, bend, and stoop as necessary
• Ability to communicate effectively, both verbally and in writing
• Ability to focus and concentrate on tasks for extended periods
• Ability to travel up to 50% via airplane and/or vehicle
• Ability to use assistive devices if needed for mobility or communication