Sr. Quality Assurance Manager (BLA preparation experience)

About the Company: KOLON TISSUEGENE is a leader in biopharmaceuticals, specializing in cutting-edge regenerative medicine. With a global footprint and a commitment to innovation, we strive to transform patient care through advanced therapies. We are at a pivotal moment and are building the dream team to bring our vision and years of efforts to life.

Job purpose

The QA Manager/Senior Manager will be responsible for the leadership and oversight of the Quality Systems at KTG. This individual will be required to provide subject matter expertise support across both GMP and GCP organizations. This position will foster Quality actions that encourages a culture resulting in behaviors, mindsets, actions and processes that provide value and alignment with International Regulations.

Duties and responsibilities

Under the direction of the Senior Director, Quality Assurance or designee, the QA Manager/Senior Manager:

• Works closely with Manufacturing regarding product quality planning, design and improvements to ensure Quality is built into manufacturing processes.
• Supports Internal audits and external vendor audits including leading audits and providing the required reports and documentation.
• Performs change control assessments to Quality Systems including document management, change control and CAPA.
• Approves Deviations and CAPAs and ensure all deviations/change controls from established procedures are appropriately documented and investigated to determine and address the root cause.
• Acts as Quality Subject Matter expert and represents Quality in internal and vendor meetings.
• Collaborates with manufacturing, clinical and regulatory groups to ensure site quality.
• Manages the QA review of Batch Records
• Manages SOP review process and assists in identifying gaps.
• Communicates changes in regulations and practices to the organization effectively and in a timely manner and aids in the development of plans to address these changes.
• Interacts with Regulatory Affairs, and Manufacturing to ensure that regulatory submissions meet domestic and international standards and regulatory requirements.
• Other Duties as assigned.

Qualifications

A minimum of Bachelors degree in a scientific discipline

A minimum of 5 years Quality Assurance Experience

A minimum of 3 years of experience in a Quality Assurance people management role

Demonstrated mastery/understanding of Quality Systems and Quality controls.

Detailed working knowledge of cGxP requirements and current FDA regulations.

***Experience in the preparation of IND and BLA applications

• Strong interpersonal skills: team building, consensus building, and conflict resolution
• Well organized and detail oriented with strong verbal and written communication skills.

Working conditions

The job is performed in a normal office environment.

Physical requirements

Position requires extensive keyboarding involving repetitive motion with fingers.

Position requires extensive use of telephone and face-to-face interactions.

Direct reports

None

Pay range and compensation package:

• Competitive salary and discretionary performance-based bonuses.
• Comprehensive health and wellness benefits package.
• Opportunities for professional development and career growth in a dynamic industry.

Equal Opportunity Statement:

Kolon TissueGene is proud to be an equal opportunity employer, fostering a workplace that embraces and celebrates diversity. We believe in creating an inclusive environment where all employees feel valued and empowered. Qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. KTG welcomes individuals from all backgrounds and is committed to supporting visa sponsorship for qualified candidates as needed.

Join KOLON TISSUEGENE at this pivotal moment and contribute to pioneering advancements in regenerative medicine while shaping a diverse and inclusive workplace. We value your unique perspectives as we deliver our mission of improving patient outcomes globally.