Senior Manger Quality Compliance

An exciting job opportunity has arisen for a Senior Manger Quality Compliance to join a leading worldwide, research-based pharmaceutical company based in Cambridge, MA. The company has over 30,000 employees worldwide, with products that include treatments for diabetes, cancer and asthma.

Job Responsibilities:

• Responsible for creating and implementing programs and compliance strategies for the O&B GMSGQ business unit.
• Ensures that these programs meet all FDA and Global affiliate GMP as well as other Global regulatory agency requirements for the markets the company manages, including but not limited to US, Japan, UK, Canada and ROW.
• Leads key compliance initiatives, both locally and globally.
• Interacts with Quality Assurance, Regulatory CMC, Supply Operations, Technical Operations, Development functions, LOCs, domestic and international Contract Manufacturing Organizations (CMOs), and regulatory agencies, including but not limited to, FDA, PMDA, MHRA, EMA, ANVISA, and Health Canada.
• Makes decisions on behalf of the company on the acceptability of compliance ongoing activities. Serves as an expert in current and emerging regulatory requirements and industry best practices.
• Directs continuous improvement to ensure programs remain compliant with FDA and other regulatory requirements, Manages the company's Inspection Readiness Program.
• Develops and maintains a broad network of relationships within the local and global environment. Represents the company at corporate and regional meetings and, as necessary, with Regulatory Agencies, industry groups and business partners
• Advises project teams on compliance strategies to ensure cGMP and company expectations are met. Ensures the establishment of remediation plans if needed to improve compliance standing.
• Leads due diligence activities to ensure risk based approaches are used and approves operations as part of self-assessment programs, Leads the Quality Council Program for the company and Regional Councils (cross-site company and Brooklyn Park) which assess compliance standing and risks associated to Quality Systems health to ensure any negative trends are properly communicated, discussed, addressed and effectiveness of actions taken monitored to assure good standing of our quality systems.
• Promote risk awareness and proactive remediation to drive compliance results.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kevin Cassini on +1 215 531 5288 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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