Covance Manager Client Engagement & Quality Assurance in Boston, Massachusetts
This position can be field based or office based anywhere in the United States.
Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
Provide local leadership and/or line management as required.
This role may be an Individual Contributor or have line management responsibilities
Essential Job Duties:
Special projects- lead/participate in QA projects- support special projects requiring QA input- support QA initiatives associated with tracking, trending and analysis of audit findings
Quality Assurance- contribute to process improvement initiatives across organization- provide support and direction to maintain global quality system to recognized standards- participate in development of QA processes and SOPs- support development of processes and SOPs by process owners outside QA *Liaison /
Representation- represent QA on project teams and other internal forums- represent QA at client meetings and/or audits- act as liaison with clients and/or their third party auditors Supervision and
Supervision and Management- Provide line management , if applicable
Business Development- contribute to the preparation of Time and Cost Estimates as requested
Level of education required (or experience level which may be substituted for level of education). Professional designations/certifications/licenses required
University/college degree, BA/BS (life science preferred) or equivalent experience
Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent experience
3 Years experience in Clinical Quality Assurance, preferably with GCP experience.
5 Years experience in other professional roles within pharmaceutical/CRO environment.
Other required work-related experiences:
Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
Financial understanding of global clinical development budgets
Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Knowledge of the drug development process from the perspective of a contract research organization
Preferred candidate with CAPA development experience
Job Number 2018-20859
Job Category Quality Assurance
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.