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CONFIRM
NEW
May 02 — 2022

(Associate) Manager, Quality Assurance

Department:CMC Location: Taipei, Taiwan Job Type: Full-time Reports to: Director of CMC and Quality

About the role

Acepodia is seeking an experienced and engaging Quality & Compliance to strengthen our Quality & Compliance function.   The successful candidate will provide hands-on support for Policies, Standards, and Global Procedures (major markets, such as US and EU), and documentation for local licensure and/or permits.
The position will ensure that a quality assurance (QA) system is in place and maintained and in compliance with Acepodia quality standards and with US GMP /PICS GMP/GTP and the local regulatory requirements; participate in building eQMS system and its implementation; and facilitate continuous improvement in support of GMP manufacturing and Technical Operations. The person will support risk-based, phased-appropriate, and timely implementation of actions.    
This position will routinely interact with other Quality functions, Manufacturing, Supply Chain, Facilities/Engineering & Validation, Information Technology, Research & Development, Regulatory and Commercial (in the future).

Education / Background

  • Bachelor’s degree or above in Sciences, Pharmacy, Engineering, or related field  
  • 3~5 years of experience in biopharmaceutical industry including quality experience in a GxP environment (biotechnology, pharmaceutical, and/or cell therapy field)
  • Fluent verbal and written communication in both English and Mandarin.

Responsibilities include, but are not limited to

  • Develop and review Quality Management System related SOPs, and responsible for their implementation
  • Support to implement e-QMS
  • Training of local personnel on quality systems and GMP requirement (training program, training record).
  • Handling of GMP/GTP deviations (including receiving, recording, investigating and closing out) to ensure timely resolution of the issues.
  • Assuring Quality changes are documented according to a formal Change Control process and that the appropriate actions are taken before implementing the changes.
  • Assuring corrective and preventive actions (CAPA) are timely defined, documented, tracked and closed in order to improve continuously the quality of the quality processes.
  • Assuring GMP/GDP critical vendors are qualified (maintaining a vendor list, assuring vendor are regularly monitored / followed up).
  • Provide support and monitor quality issues resolution within the organization and with the external suppliers.
  • Handling and escalation of complaints received from costumers (including receiving, recording, investigating and closing out).
  • Coordinating product recalls and withdrawal of the local country, including investigational medicinal product (IMP).
  • Develop GMP and QA knowledge and implementation to its highest standard, which is essential for the company to maintain its strong quality.

Position Requirements, Relevant Skills & Experience: 

  • Critical requirements for the position:
  1. In depth knowledge of international regulations, concepts, industry practices and standards
  2. Strong working knowledge and experience of GxP regulations, quality systems, and regulatory guidance documents in US and EU
  3. Experience in quality systems (e.g., deviations, CAPAs, change control, training, complaint handling) and validation processes and systems
  4. Experience implementing quality management policies and procedures
  5. Management/leadership experience
  6. Clinical manufacturing or commercial manufacturing experience
  • Strongly preferred:
  1. Understanding and experience of cell therapy processes
  2. Knowledge/experience in aseptic manufacturing processes and procedures 
  3. Project management experience
  • Personal Skills:
  1. Demonstrated problem-solving and critical thinking skills.
  2. Strong courage of conviction and conflict resolution skills
  3. Ability to work effectively in a dynamic, complex, and fast paced team environment.
  4. Excellent interpersonal, verbal, and written communication skills
  5. Demonstrated ability to multi-task effectively and adjust workload based on changing priorities.
  6. Self-motivated, technically driven, and willing to take on duties outside of general responsibilities.
  7. Proactive and self-motivated, be a strategic and creative thinker, be highly proficient in project planning, be highly organized, have an ability to prioritize and meet tight deadlines, and demonstrate calmness in times of uncertainty and under stress.

Contact Us to Apply

Acepodia is an equal opportunity employer offering a competitive salary and comprehensive package, including stock options, medical care, paid vacation, and holiday time. Title and salary commensurate with experience.
 

About Acepodia

Acepodia is a clinical-stage biotechnology company developing NK and γδ T cell therapies using our patented ACC (Antibody Cell-Conjugation) technology platform. Using ACC technology, we arm immune cells with antibodies to target and eradicate cancer cells. Our mission is to develop safe, effective, and affordable cell therapies to fight and beat cancers.

Founded in 2017 in the birthplace of biotechnology, the San Francisco Bay Area, CA. Acepodia is venture capital and private equity backed and funded. Our platforms and products aim to address and overcome the major obstacles in cancer therapy: Ability to target low expression of tumor antigens to better prevent tumor escape; Trafficking of effector cells to tumor locations; Activate the immune system to attack cancer cells.
 

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