senior specialist quality systems and compliance in Basel

posted
contact
Laura Deola, Basel Professionals Health Care & Life Sciences
job type
temporary
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job details

posted
location
basel, basel-stadt
sector
life sciences
job type
temporary
reference number
15169
contact
laura deola, basel professionals health care & life sciences
phone
058 201 55 50

job description

To work for our client, a pioneering biotechnology company, we are looking for a: 

 

 Sr. Specialist, Quality Systems and Compliance 

 

Location:Basel

Contract: to start asap for one year.

 

Reporting to the AD/D of Quality Systems and Compliance, the Sr. Specialist Quality Systems and Compliance will be responsible for supporting implementation of quality system processes and operations to ensure the company exceeds the highest level of compliance while monitoring the health of the Quality Management System (QMS) for continuous improvement in support of the international organization. 

The Sr. Specialist will participate in internal, supplier quality and health authority audits, support document control, training and records management, assist in building a culture of quality at the site and oversee QMS in support contract testing and manufacturing facilities and overall international operations for clinical and commercial products. 

The incumbent will be an integral partner to the innovative technology platform as they continue to integrate automation and digital technology into everything they do. 

 

Your Responsibilities: 

 
  • Implement and manage the company's overall Quality Management System (QMS) and quality manual, policies and procedures for the international organization and ensure continuous improvement while keeping it current with emerging and changing international regulations, guidance documents and current industry best practices and expectations. 

  • Provide cross functional quality leadership and act as a GXP compliance subject matter expert on technical matters involving product examination, testing and disposition, quality investigations, validation, data integrity, and in business matters involving facility and laboratory operations. 

  • Work collaboratively with the digital team on the GXP integrated digital landscape to support all e-systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning. 

  • Oversee the performance of the QMS by participating in Management review meetings and monitoring the state of control through metrics and key performance indicators for the company's international organization.

  • Implement practices in document and records control, management, and retention to ensure robust training, compliance, data integrity, and continuous improvement for the rapidly expanding GXP international environment.  

  • Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity.

  • Perform audits (lead)  in support of the internal and supplier quality audit programs and support third party/regulatory inspection programs for the international organization. 

  • This role requires up to 40% international travel. 

 

Your profile:

 
  • Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years.

  • Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in participating in successful regulatory inspections.

  • Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry.

  • Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way. 

  • Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.

  • Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment. 

  • Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

  • Ability to navigate through ambiguity and rapid growth and adapt to change. 

  • A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

 

Please note that a valid Swiss work permit or Swiss or EU-25/EFTA citizenship is required for this position