Octapharma Plasma, Inc. · 8 hours ago
Assoc. Dir - Quality Compliance
Charlotte, NC
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expOctapharma Plasma, Inc. is a growing company focused on enhancing career development and opportunities in the healthcare sector. The Associate Director of Quality Compliance will design and manage compliance strategies, oversee quality exception processes, and lead a high-performing team to ensure regulatory compliance and continuous improvement initiatives.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Design and manage the development and execution of compliance strategies aligned with company policies and applicable national and international regulations including requirements of self-regulating industry organizations such as Plasma Protein Therapeutics Association (PPTA)
Develop and oversee a comprehensive process for managing donor center Quality exceptions ensuring timely investigation, root cause analysis, resolution, and cross-functional coordination, while maintaining regulatory compliance and monitoring the effectiveness of corrective and preventative actions
Establish and implement a standardized process for reviewing donor center Quality records, ensuring timely investigation, resolution of exceptions, while maintaining regulatory compliance and monitoring the effectiveness of corrective and preventative actions through coordinated cross-departmental efforts
Lead analysis of internal and external audit data to identify trends and deliver metric reporting and insights that inform strategic decisions
Lead the development and implementation of audit plans, procedures, and systems to ensure compliance with relevant rules and regulations, while collaborating with other teams to ensure accurate and timely submissions of audit responses
Oversee the development and delivery of training initiatives on regulatory compliance, QMS procedures, exception management, and continuous improvement, ensuring internal and field team members are properly trained and competent in QMS responsibilities relevant to their role
Lead continuous improvement initiatives to enhance the effectiveness and efficiency of the QMS policies by analyzing exception trends, identifying systemic issues, and implementing process improvements
Lead, support, and develop a high-performing Quality Compliance team by setting goals, fostering development, and promoting a culture of accountability and regulatory excellence
Ensure that organizational facilities and key suppliers maintain Quality Assurance (QA) compliance as defined by internal company policies, procedures, and requirements outlined by external regulatory agencies
Provide strategic oversight of supplier qualification by reviewing documentation and regulatory requirements, resolving compliance gaps, and collaborating with internal stakeholders ensuring alignment with regulatory exceptions and maintenance of approved vendor lists
Perform other duties as assigned
Qualification
Required
Associate's degree in a relevant field (e.g., Engineering, Life Sciences, Quality Management)
Five (5) years of experience in quality assurance or quality systems roles within an FDA-regulated industry (e.g., biologics, pharmaceuticals, medical devices, biotechnology)
Two (2) years of experience in a people management role
Knowledge of FDA regulations (21 CFR Part 640 Subpart G Source Plasma)
Strategic thinker with demonstrated experience in the development and management of quality systems, exception identification and resolution, CAPA programs, and continuous improvement initiatives
Ability to lead and develop high-performing teams and drive a culture of quality and compliance
Proficiency in quality management software and tools
Strong analytical, problem-solving, and data interpretation skills
Must have excellent organizational skills and be detail-oriented
Ability to build relationships across levels and functions
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 navigate the office environment safely, including stairs and elevators (if applicable)
Ability to travel up to 20% via airplane or vehicle (if applicable)
Ability to use assistive devices if needed for mobility or communication
Preferred
Bachelor's degree preferred
American Society for Quality (ASQ) certification or equivalent preferred
Company
Octapharma Plasma, Inc.
About Us: Octapharma Plasma, Inc. helps change lives through the incredible power of plasma donation.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Judy Smith
COO and EVP
Barry Pomeroy
Vice President - Finance
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2025-09-26
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