Role Description

Executes critical actions that enforce organizational adherence to corporate quality and compliance processes, including quality management systems reviews, data integrity assessments, and risk management assessments. Leads donor centers and shared services with external inspections (e.g. regulatory, customer, etc.). Directs audit planning and response activities and oversees Plasma Master File (PMF) updates to ensure donor center compliance with regulatory requirements, Standard Operating Procedures (SOP), current Good Manufacturing Practices (cGMP), and customer expectations.

Primary Responsibilities

• Leads the development of Site Master Files (SMFs) required for external EMA inspections, driving cross-functional collaboration with donor centers and center support leadership to ensure accuracy and compliance.
• Serves as the organization’s lead representative by delivering expert on-site and remote support during inspections conducted by Regulatory Authorities.
• Provides strategic support to center leadership by leading the development, authoring, and critical review of external audit responses and CAPA plans addressing donor center citations.
• Leads the development, authorship, and critical review of internal and external audit responses and CAPA plans addressing corporate citations.
• Directs and oversees the coordination, organization, and authorship of final regulatory inspection responses for submission to agencies including FDA, EMA, CLIA/COLA, PPTA, State authorities, Health Canada, and internal compliance auditors.
• Provides comprehensive support to donor centers by overseeing customer audits, delivering high-quality customer-requested documentation, and leading the development of robust audit responses.
• Conducts high-impact QMS assessments, evaluating procedural compliance, process robustness, and operational risk to strengthen the organization’s audit readiness posture.
• Drives strict compliance across donor center and corporate operations by rigorously evaluating procedures and processes against all applicable Domestic and European regulations.
• Proactively identifies systemic improvement opportunities through comprehensive analysis of audit findings and delivers targeted solutions to strengthen compliance with Domestic and European regulations, Standard Operating Procedures (SOPs), customer specifications and related quality requirements.
• Supports the department manager by driving the initiation of Change Requests and authoring Standard Operating Procedures based on identified trends, audit findings, and direct engagement with facilities.
• Evaluates deviations and analyzes tracking and trending data to drive continuous improvement initiatives.
• Frequently serves as the department's representative on organizational initiatives to ensure compliance with regulations, SOPs, and customer requirements.
• Travels up to 25% or greater if demand requires.

Additional Responsibilities

• The incumbent must have the ability to write clear, concise, logical responses to regulatory authorities.
• Understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
• Know the European Pharmacopoeia (EP) and other European Guidelines as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
• Have strong interpersonal skills with the ability to communicate effectively, both written and verbal, with persons from other cultures and other points of view.

Knowledge, Skills, and Abilities

• Must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
• Must know the European Pharmacopoeia (EP) as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
• Must know CLIA/COLA/PPTA regulations as they apply to Source Plasma and be able to support State required inspections as needed.
• Maintains a high level of professionalism.
• Follows policies, procedures, and regulations governing work and the work environment.
• Models and demonstrates high standards of integrity, trust, openness, and respect for others.
• Takes initiative; looks for opportunities to act and contribute to the team's success.
• Demonstrates good stewardship of expenses and makes good use of unsupervised time.
• Offers support to team members at any level in achieving their goals.
• Provides outstanding servant leadership and receives feedback constructively.
• Appropriately follows the chain of command and knows how to get tasks accomplished.
• Demonstrates openness to team members’ suggestions.
• Shares knowledge, resources, etc. to reach common goals.
• Demonstrates effective oral and written skills and communicates information accurately based on fact.
• Uses respectful, conversational tones in e-mail messages.
• Understands the impact of own behavior on others – and adapts to change with optimism.
• Demonstrates critical thinking and attention to detail; ability to think through problems clearly and logically.
• Completes assigned tasks within the required timelines.
• Listens and communicates in a transparent way, building relationships that foster professional self-esteem.
• Acts as a role model of the corporate values and reinforces them among his/her team.
• Uses facts and figures to support positions and influence others.
• Promotes and applies professional ethics.
• Knowledgeable of current regulatory standards.
• Organizes tasks and projects effectively.
• Demonstrates and encourages good teamwork and high levels of collaboration.
• Contributes feedback where necessary.
• May represent department on projects, workgroups, Process Improvement Teams.
• Builds strong and trustworthy working relationships with team members and internal/external partners.
• Focuses on the scope and the solution rather than the problem; strives to overcome possible obstacles.
• Shares innovative ideas, creates buy-in and translates ideas into practice.
• Looks for simplification and improvement of processes; creates simple procedures and alternatives that may benefit the company.
• Embraces change and continuous improvement.

Education and Experience

• Bachelor’s degree required.
• Minimum 5 years experience in quality assurance related field.
• Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.

Occupational Demands

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently sits for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Frequently walks.
• Occasionally bends and twists neck.
• Light to moderate lifting and carrying objects with a maximum lift of 30lbs.
• Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Interacts with others, relates sensitive information to diverse groups.
• This position requires 50% and up travel for occasional meetings, trainings or center visits for audits.

Compensation and Benefits

• The estimated pay scale for the Quality Audits Specialist role based in the Central or East Coast, is $77,462.00 - $116,194.00 per year.
• Eligible to participate in up to 8% of the company bonus pool.
• Wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and up to 5% 401(K) match and tuition reimbursement.
• Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data.
• Opportunities for professional growth and career progression.