At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https: //www.jnj.com

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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Position Summary:

Responsible for the Site Quality Department, including all product quality, quality compliance and controlled substance related activities at site. Is accountable for adequate monitoring of the quality systems to ensure that it is adequately managed, and products manufactured at site is properly inspected, tested, packaged and released to the Japanese Market. Quality metrics is managed through the Tier system and BPM. Must also support the Qualified Person and other legal positions in the department. Also supports the introduction of the NPI into the Japanese market.

In addition, also responsible for guiding, mentoring, coaching, training, and developing both the quality units and other departments personnel at site.

Communicates department objectives aligning with regional, site and Japan BU objective. Participate in planning and implementing overall global and site strategy.

Also responsible for championing Credo, Quality Culture, and reliability improvement activities at the site.

Regulatory Compliance Responsibilities:

The Quality Department must be compliant with the following laws and regulations (but not limited to):

• Pharmaceutical and Medical Device Act
• Japanese GMP
• Narcotics and Psychotropics Control Law
• GCTP Ordinance
• Official compendium such as JP, USP and EP etc.
• EHS standards and related regulations such as Poisonous and Deleterious Substances Control Law etc.
• Corporate standard and JSC SOPs.

Major Job Duties and Responsibilities:

• Responsible monitoring the effectiveness of the sites quality system and compliance through forums such as the following but not limited:
• Management Review
• Quality Council
• DI Council
• Site quality risk register
• Tiers and BPM
• Monthly and quarterly reports such as APR, complaints
• Validation steering committee
• Participate and support Site initiatives which are identified through requirements of the site SLT and Board Meetings
• Champions site initiatives such as DI, Credo and Quality Day, and quality culture

Qualifications

Education and Experiences:

• Bachelor's degree or equivalent education in science, chemistry, biology, biotechnology, microbiology, or related fields
• A minimum of 15 years’ experience within the biological, pharmaceutical and or medical device industry.
• Knowledgeable of PMDA/MHLW/GCTP/JP regulatory requirements applicable to biologics and/or pharmaceuticals.
• Advanced degree (MS, MBA, PhD) preferred.

Knowledge, Qualification and Skills:

• GMP, Narcotics, Psychotropics, QMS and Data Integrity
• Pharmaceutical regulations, standards, and guidelines
• Effective communication in Japanese and English
• Proficiency with Microsoft Office software programs are required.

Core Competencies:

• Credo value of integrity
• Comply with EHS rules and procedures at all times
• Report all incidents, accidents, and near miss events
• Collaboration and teamwork
• Excellent interpersonal skills
• Ability to operate as part of a team is critical
• Customer focus
• Excellent communication skills both written and verbal
• Good problem-solving and coaching skills.

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