Sr. or Principal Quality and Compliance Manager
In this fast-paced and varied position, you will serve as an important conduit to the broader organization to ensure a culture of compliance through well thought out, actionable, aligned and achievable Good Clinical Practice (GCP) related processes and procedures. You will communicate and interface with a host of internal cross-functional partners, both within our company and Early Development (gRED) and other functions, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance.
Interacts cross functionally with Drug Safety, Quality Assurance/ Risk Management, Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, and Medical Affairs to ensure SOPs, Policies or Work Instructions are in place.
Collaborates with our Early Clinical Development (ECD), Quality and Compliance Office (QCO) to implement and maintain the Functional Quality Management System (QMS) and its related documents, in alliance with the Quality principles outlined in the company Quality Manual.
Provides expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct and/or regulated drug development activities.
Communicates controlled document and policy changes within/across the gRED organization.
Serves as a consultant to management and act as an internal/external spokesperson for the organization on matters pertaining to policies, quality plans, objectives and business goals.
Proactively researches, evaluates and makes recommendations associated with evolving laws and regulations. Benchmarks and stays abreast of other industry and marketplace developments and best practices.
Effectively integrates compliance risk/context and business knowledge to address unusually complex problems. Keeps current in the area of healthcare compliance, GCP, GVP, and company policy and procedures.
Recommends and drafts new or amended policies & SOPs in support of regulatory policy, law and regulations while specifying actual or potential implications to existing business operations, procedures and practices.
The right candidate will possess the following skills and experience. The level of the position will depend on the qualifications of the selected candidate.
Bachelor's degree, preferably in medicine, pharmacy or other healthcare discipline.
10+ years of relevant experience in pharmaceutical drug development, preferably in regulatory compliance and/or with quality responsibilities within a drug development organization.
Working knowledge of GCP/ICH and HIPPA health information privacy requirements within a global pharmaceutical organization.
Strong influencing skills. Track record of building and cultivating relationships with key partners and stakeholders across organizational levels.
Strong negotiation skills. Ability to drive discussions and decisions toward desired end-results.
Strong verbal and written business communication skills. Highly adept at synthesizing and summarizing complex and/or voluminous content into clear, concise and actionable communications.
Strong process-orientation. Proven effectiveness in identifying, developing and implementing scalable/sustainable process and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
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