Syneos Health - Germany

Global Clinical Quality Manager

Location
Homeworking, Switzerland,
Salary
Competitive
Posted
02 Aug 2021
Closes
06 Aug 2021
Ref
21008690
Discipline
Quality
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Global Clinical Operations Quality Manager

Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.

Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Summary:

The Global Quality Manager, Development Operations provides global strategic and tactical leadership with our study teams and countries to achieve overall quality goals, support for regulatory inspections, process alignment and documentation. These activities will be in collaboration with Quality Assurance Group. This position can be fully home-based, if this is what the candidate prefers, but if not, there is the option to work from the office, which is in the French side of Switzerland, serving directly a big pharma company client there.

Key responsibilities:

• Point of contact for quality and compliance questions and work with QA to ensure alignment and consistent messaging to team based on GCP and regulatory requirements.

• Support team in identifying, escalating and putting risk plans in place to mitigate risks. • Provide training to study teams, as needed

• Support teams in preparation for regulatory inspections of sponsor, country, site and vendor inspections

• Ensure adherence to GCP and overall quality as point of contact globally for sponsor study records.

• Support overall quality within on-going studies and submissions

• Work with teams to address quality issues with CROs and help teams bring them back in to compliance.

• Contribute and support facilitation, presentation and communication of lessons learned

• Derived proposals from Lessons Learn for process improvement

• Review critical/major findings with QA Audit reports to propose process improvement

• Support Teams in developing CAPA

• Collaborate with QA for information needed and requested for any global inspections

• Support teams in developing SOPs/WIs (global, regional, local)

• Review any SOPs/WIs development

• Support operational diagnostics to identify opportunities for improvement

• Provide input to Quality Plans

• Measure progress and targeting of results from improvement projects

• Develop matrix relationships to involve process experts and conduct improvement activities

• Ensure integration and alignment across organization

• Stay abreast of clinical trial requirements, FDA, EMA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.

• Become thoroughly familiar with assigned compounds and protocols.

• Facilitation and support of cross functional stakeholdersWhat we're looking for:

• Min Bachelor's degree, and fluency in English

• Solid GCP experience (GLP or GMP experience will not be considered)

• Experience with driving process improvement activities impacting Development Operations

• Experience with process improvement activity leading/involvement and/or procedural document development

• Min of 5*+ years' experience in a pharmaceutical or bio-pharmaceutical company in a Quality role

• Understanding of Clinical Operations activities

• Experience with EMA, EU sponsor/site audits

• Experience in developing processes and/or SOPs and/or WIs

• Strong written and oral communication skills.

• Prior Regulatory inspection experience desired.

• Ability to travel

#LI-AM3

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.