Manager, Global Product Quality - Clinical Packaging

The Manager, Global Product Quality – Clinical Packaging is responsible for ensuring GMP and GCP compliance in the packaging, labeling, and distribution of clinical trial materials across global operations. This role supports the oversight of clinical packaging activities performed internally and at external vendors, ensuring that quality standards are met and regulatory requirements are maintained throughout the clinical supply chain.

The manager will collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, and Supply Chain to ensure the integrity and traceability of investigational products from packaging through delivery.

Key Responsibilities

• Oversee clinical packaging operations to ensure compliance with GMP, GCP, and applicable global regulatory requirements.
• In collaboration with the supplier quality team, support qualification and monitoring of external clinical packaging vendors, including audits and performance reviews.
• Review and approve packaging documentation including batch records, labels, and packaging specifications.
• Ensure proper implementation of packaging and labeling requirements for investigational products across global clinical trials.
• Collaborate with Clinical Supply Chain and Regulatory Affairs to ensure timely and compliant delivery of clinical materials.
• Support deviation investigations, CAPA implementation, and change control related to clinical packaging activities.
• Maintain and update SOPs, work instructions, and quality documentation related to clinical packaging processes.
• Provide training and guidance to internal teams and external partners on packaging quality requirements.
• Participate in periodic reviews of quality systems and contribute to improvement initiatives.
• Prepare and contribute to quality metrics and reports for management review.

Qualifications

Required

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related field.
• Minimum 5 – 7 years of experience in a regulated industry (pharmaceutical or medical device), with 3–5 years in Quality Assurance or Supplier Quality roles.
• Familiarity with FDA 21 CFR Parts 210, 211, 820, and Part 11 requirements.
• Strong organizational and communication skills.
• Ability to manage multiple tasks and work collaboratively in a team environment.
• Proficiency in MS Word, Excel, and Access; experience with quality systems (e.g., TrackWise) is a plus.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings;