342343BR
Mar 28, 2022
Germany

Job Description

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide.

For our GCP Compliance team of our Biopharmaceutical Clinical Development (BCD) unit in Holzkirchen, Germany we are looking for a

Senior Compliance Manager (d/f/m)

Job purpose

The Senior Compliance Manager is responsible for mentoring and coaching compliance managers, creating/executing the vision, strategy & objectives for the GCP Compliance group, ensuring proactive compliance and inspection readiness are integrated into planning and execution of clinical trials and supporting audit/regulatory inspection(s).

The Senior Compliance Manager provides guidance to functional/clinical trial and program teams on Clinical Trial Quality Risk Management (CTQRM) and GCP related activities/issues.

Key responsibilities:

• Provide coaching, guidance, and mentorship to compliance managers
• Support to create the vision, strategy & objectives for GCP Compliance group and independently develop and execute initiatives & activities to deliver against defined vision & objectives
• Operational oversight of outsourced monitoring activities, including CRO/site oversight visits as a study compliance manager to ensure proactive risk & compliance activities are integrated into planning and execution of assigned clinical trial(s)
• Identify and anticipate quality issue trends and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion
• Provide support and guidance to functional/clinical trial teams in drafting responses to address audit/inspection findings
• Lead/support inspection readiness activities in close collaboration with Clinical Quality Assurance and ensure clinical trial team members are trained and prepared for regulatory inspections
• Conduct pre-inspection visits at investigational sites/third party vendors to support inspection readiness activities
• Provide guidance on regulations, GCP and other guidelines to functional/clinical trial and program teams.
• Maintain or update Standard Operating Procedures (SOPs), Working Practices (WPs) and Policy Documents in the area of compliance

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Bachelor’s degree or equivalent qualification in life science/healthcare, Master's degree is preferred
• At least 8 years clinical/industry/health authority experience, including at least 3 years with focus on quality and compliance (GCP auditor background preferred)
• In-depth knowledge of current regulatory and ICH GCP requirements. Strong experience of CAPA management, risk management and audits/regulatory inspections (e.g. FDA, EMEA)
• Experience in contributing to or authoring Standard Operating Procedures (SOPs), Working Practices (WPs) and job aids
• Experience leading or participating in process improvement initiatives
• Strong interpersonal, problem-solving, negotiation and conflict resolution skills
• Strong project management and organizational skills
• Very good written and verbal communication
• Effective in establishing and maintaining good collaborations across functions, business units and external partners
• Has a growth mindset
• Willing to travel (approximately 30%)

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
SANDOZ
BioPharma SZ
Germany
Holzkirchen (near Munich)
Research & Development
Full Time
Regular
No
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342343BR

Senior Compliance Manager (d/f/m)

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