Quality Manager Process SM

at  Johnson Johnson

Johnson & Johnson is currently seeking a
Quality Manager Process SM (m/f/d)
to join our team located in Schaffhausen, Switzerland.
(1-year fixed term employment contract)
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/.
Position summary:
The Quality Manager in Small Molecules is leading a team of individual contributors and/or supervisors in support of the execution of processes and activities related to fulfilling the Quality Assurance requirements for the organization’s products. Ensures key quality deliverables are completed in accordance with required timelines. Provides coaching and guidance to team in the identification of risks and development of mitigation plans, monitoring of data, and development of significant KPIs. Is accountable for conducting effective performance management and establishes a culture of continuous improvement, growth, and development.

Key responsibilities:

• Main goal is the assurance that the Small Molecules manufacturing processes are in compliance with HA regulations and J&J standards in terms of quality, regulatory and EHS requirements in agreement with cGMP regulations.
• Organization and lead of the Small Molecules Process team and ensuring the training and development of the group
• Ensure timely batch disposition decision for batches manufactured in the Small Molecules business unit
• Handling of Quality Investigations, CPAs, COCs, Corrections and other quality records
• Review & Approval of workflows and master data
• Review and approval of SOPs, WIs and other documents for the department
• Quality responsibility for all topics related to GMP compliance for the department incl. qualification and validation activities
• Site representative in global meetings
• Ensure quality oversight and quality on the shop floor in the department
• Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
• Training coordinator for Small Molecules Process team
• Ensures inspection readiness for the BU Small Molecules
• Participates in audits and inspections of the Small Molecules BU

QUALIFICATIONS

Required:

• 6-10 years of work experience and is a plus experience in a leadership position within the biological and/or pharmaceutical industry.
• Degree or equivalent in a scientific or engineering field.
• Proven understanding of regulatory requirements and quality standards.
• Exceptional attention to detail and a commitment to producing magnificent results.
• Daring and driven, with a track record of successfully implementing quality improvement initiatives.
• Excellent communication and leadership skills.
• Ability to work as a strategic partner with all other departments within the company.
• Experience in a Quality leadership role required.
• Proficient in the English language (speak, read & write).

Other:
This position may require up to 10% domestic & international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation

• Main goal is the assurance that the Small Molecules manufacturing processes are in compliance with HA regulations and J&J standards in terms of quality, regulatory and EHS requirements in agreement with cGMP regulations.
• Organization and lead of the Small Molecules Process team and ensuring the training and development of the group
• Ensure timely batch disposition decision for batches manufactured in the Small Molecules business unit
• Handling of Quality Investigations, CPAs, COCs, Corrections and other quality records
• Review & Approval of workflows and master data
• Review and approval of SOPs, WIs and other documents for the department
• Quality responsibility for all topics related to GMP compliance for the department incl. qualification and validation activities
• Site representative in global meetings
• Ensure quality oversight and quality on the shop floor in the department
• Compliance with the GMP, EHS and SOX requirements and guidelines, which are connected to the respective function.
• Training coordinator for Small Molecules Process team
• Ensures inspection readiness for the BU Small Molecules
• Participates in audits and inspections of the Small Molecules B