Senior Manger Quality Compliance
This vacancy has now expired. Please see similar roles below...
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.
#LI-KC1
Related jobs
Highly Competitive
Frankfurt am Main (60488), Germany
Proclinical are seeing a Clinical Application Specialist for a position based in Frankfurt.
£45000 - £55000 per annum
City of London, England
Proclinical are searching for a dedicated professional for a Senior Clinical QA Specialist (GCP).
Up to £0.00 per annum
Zürich, Schweiz
Proclinical are currently supporting is a global management and technology consulting group as they are looking to recruit a Senior SAP FI/CO Consultant in Zurich, Switzerland.
Highly Competitive
Crailsheim (74564), Germany
Proclinical are seeking a dedicated Technical Project Manager to lead software development projects in the medical technology field.
Highly Competitive
Zürich, Schweiz
Proclinical are recruiting for a Senior Software Developer Java to join a consultant. This role is on a permanent basis and located in Zurich.
Highly Competitive
City of London, England
Proclinical are searching for a Clinical Project Manager for a fully remote role within the UK.
Up to US$27 per hour + Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Cell Manufacturing Associate to join a cutting-edge cell and gene therapy company.
Highly Competitive Salary
Rockville, USA
Proclinical is seeking a dedicated and innovative QC Microbiologist with a focus on endotoxin detection methods. This is a contract position located in Rockville, MD.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated Talent Acquisitions Coordinator. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
Wilmington, USA
Proclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing.