Assoc. Dir - Quality Compliance

Overview

Want to Expand your career-development potential, your ability to help donors and patients, and your access to professional opportunities?

We’re growing fast. There are many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:
Associate Director-Quality Compliance

• 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.

• Associate’s degree in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
• Bachelor’s degree preferred.
• 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.
• American Society for Quality (ASQ) certification or equivalent preferred.
• 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.

• Physical Requirements
• Ability to sit for extended periods of time.
• Ability to use a computer…