\\n Randstad (Schweiz) AG

For our client, an international company in Zurich, we are looking for an
Associate Director Regulatory Compliance

- Start date: ASAP
- End: Permanent
- Workplace: Schaffhausen
- Workload: 100%
At the Pharmaceutical Companies of ..., we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.

The Large Molecule Regulatory Compliance lead is accountable for regulatory compliance of the Large Molecule Platform within the .... Supply Chain. The Lead is responsible for compliance oversight and execution of key compliance programs to drive proactive and sustained compliance, in order to enable delivery of business needs. The Lead directs a team(s) of compliance professionals to execute tactical compliance activities.
Key Responsibilities:
- Serve as an expert regulatory compliance advisor and Subject Matter Expert on key strategic and critical compliance issues for the Large Molecule Platform.
- Understand site risk profiles and proactively identify and prioritize risks. Partner with stakeholders to escalate critical risks to the appropriate levels of management.
- Provide compliance expertise and global compliance perspective in the development of risk mitigation strategies. Make decisions regarding the applicability of cGMP and other Health Authority regulations to sites in the Large Molecule network.
- Lead a team(s) of compliance professionals to provide compliance oversight and execute compliance programs to ensure compliance with all voluntary, regulatory, and statutory standards.
- Represent Large Molecules Regulatory Compliance in applicable Q&C and/or JJRC forums and councils. Act as deputy for Large Molecules Regulatory Compliance Head.
- Understand and communicate emerging external regulatory compliance issues and trends.
- Establish organizational talent strategy to include goals and objectives, performance and development and career and succession planning.
- Accountable for performance management, personnel development and timely completion of 5 Conversations.
- Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices.
- As applicable, conduct and/or facilitate assessments (e.g., Pre-PAI Audits, Due Diligence Audits, Gap Analyses) to support business needs and assess compliance risk for the organization.
- Partner with stakeholders to drive implementation of new and revised regulatory requirements and expectations
Must Haves
- A minimum of a bachelor\\\'s degree in science or another related field (required)
- A minimum of 10 years of experience in Quality Assurance, Operations, and/or Regulatory Compliance
- Experience managing various aspects of Quality and Regulatory Compliance
- Experience working in the Pharmaceutical, Medical Device, or Consumer regulated healthcare environment
- Experience working with, or for, the United States Food and Drug Administration (FDA) and other foreign regulatory agencies
- Demonstrated track record of achieving successful compliance outcomes, remediating compliance issues, and supporting regulatory agency inspections
- Ability to build partnerships, manage complexity and mediate issues
- Utilizing influential leadership, the ability to build consensus and impact outcomes without always having line authority; able to negotiate trade off decisions across the organization
- Strong analytical skills and experience implementing risk-based oversight programs
- Strong executive presentation skills
- Demonstrated track record of leading direct or indirect teams to delivers results
- Ability to balance technical understanding of products and processes with compliance perspective and business acumen

Preferred:

- Experience working with large molecule (e.g. biotechnology, cell therapies and/or vaccines)
- Detailed knowledge of Pharmaceutical sector regulatory requirements

Other:

- This position may require up to 40 percent of travel both internationally and domestically.
Temporary

Branche: Anderes

Funktion: Anderes\\n \\n \\n \\n \\n \\n

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