Quality Assurance Manager

About the Company:

Celltrion USA is Celltrion’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. Celltrion Healthcare, which suggested a new growth model in the Korean biopharmaceutical industry through biosimilars, is now advancing to new challenges to become a global pharmaceutical provider. Just as it has overcome many obstacles in the past, Celltrion Healthcare will successfully pave the path for global direct selling, which has never been achieved yet by Korean biopharmaceutical companies. As it continues to surpass its current success, Celltrion Healthcare will take a leap forward to become a leading global biopharmaceutical company.

Celltrion Healthcare provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world.

POSITION SUMMARY

Responsible for management of quality assurance department of Celltrion USA. Operate and maintain a quality system for the distribution of biopharmaceutical products, ensuring full compliance with Good Distribution Practice (GDP), including 21 CFR Part 210/211 or 21 CFR Part 820

KEY ROLES AND RESPONSIBILITIES

• Make decisions related to Quality issues in support of company’s business and operational objectives
• Report directly to the Quality Assurance Director routinely to ensure that Quality Assurance Director is adequately and timely informed of the status of the quality system
• Review and approve all quality activities, including review and approval of all quality system SOPs
• Review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the applicable requirements of the Quality System Regulation (QSR) as set forth under 21 C.F.R. Part 820 and CELLTRION USA's established quality policies, procedures, and objectives
• Ensure quality system procedures and instructions are established and maintained
• Provide quality compliance guidance and training to all staff on QMS SOPs and its applicable provisions
• Lead initiatives for the continuous improvement of the quality system and ensure that measurable results are achieved
• Stay current on industry best practices, trends, and relevant regulatory intelligence
• Provide regular communication across all divisions, including the marketing and sales organizations, regarding Quality System management for Good Distribution Practice(GDP)
• Manage routine quality meetings with staff and Celltrion’s Corporate QA team
• Collaborate with Celltrion’s Corporate QA team on the management of quality systems at Celltrion USA
• Conduct on-site or remote audits of Third-Party Logistics(3PL) sites and other services providers.

WORK EXPERIENCE

• 10 years’ experience in quality assurance (QA) at a pharmaceutical company
• Prefer to have 3-5 years in a manager role in a biotechnology/LifeScience industry or specifically in the Good Distribution Practice (GDP) of biopharmaceutical products.
• Strong knowledge of Quality Management Systems(QMS) for the Good Distribution Practice (GDP) of biopharmaceutical products

SKILLS AND SPECIFICATIONS

• Excellent oral and written communication skills
• Recognized as a great listener, learner, and strategic contributor
• Proven management skills including communicating with executive management
• Experienced in the management of a regulated medical products company

EDUCATION

Bachelor's degree or above.

CORE COMPETENCIES

Ethics and Values

Regulatory Knowledge

Conflict Management

Problem Solving

Personal Learning

Action Oriented

Timely Decision Making

Organizational Agility

Drive for Results

Celltrion USA is an equal opportunity employer. It is our policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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