Cardiovascular Clinical Sciences
The Quality Assurance Manager is responsible for overseeing the company’s Quality Management System (QMS), ensuring compliance with all relevant clinical, regulatory, and industry standards, and driving continuous quality improvement across processes and deliverables.
The following information provides an overview of the skills, qualities, and qualifications needed for this role. Ideal candidates will be local to Boston. Remote candidates able to travel to Boston occasionally will be considered. ●Develop, implement, and maintain the QMS in a state of compliance in accordance with FDA, ICH, ISO, and GxP requirements. Routinely monitor the regulatory environment for changes in regulations and guidelines impacting CCS and incorporating new requirements into CCS processes ●Oversee compliance of CCS’ core business processes. Monitor Key Performance Indicators, clinical program level trends, perform root-cause-analysis (if necessary) and develop action plan to support process improvement ●Serve as the Management Representative for the QMS and conducts Management Review meetings with senior management to discuss and address compliance issues, develop and review quality initiatives in support of continuing process improvement ●Plan and conduct internal and external audits of clinical trial processes, vendors, and documentation ●Host and coordinate regulatory inspections and sponsor audits ●Work directly with Department Heads in the development of new policies, and updating of current procedures and work instructions to ensure the quality of clinical trial process and data ●Oversee and manage change control, document control, deviation handling, and compliance activities ●Deliver and document training for key stakeholders on regulations and standards relevant to clinical research ●Lead the investigation and resolution of quality issues, including Deviations and CAPAs ●Provide QA compliance guidance and support to functions across the organization including Project Management, Clinical Operations, Safety, Biometrics, Core Laboratory and client-related projects ●Collaborate with clinical vendors Qualifications: ●Bachelor’s or advanced degree in life sciences or related field (required) ●7 plus years of Quality Assurance experience preferably in a Contract Research Organization, Pharmaceutical, or Medical Device environment ●Demonstrated leadership in QA; proven auditing and regulatory inspection experience ●Strong interpersonal skills for interactions with internal and external clients ●Able to work independently ●Ability and willingness to travel as needed Knowledge & Skills: ●Strong working knowledge of FDA, ICH, ISO, GxP, pharmaceutical, and medical device regulations for clinical trials Excellent written/oral communications and analytical skills ●Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike ●Proven organizational, prioritization, and teamwork abilities ●Adept at working independently and collaboratively in fast-paced settings ●Enthusiasm, attention to detail, results-driven, high integrity ●Expertise in Computer System Validation within regulated environments, including developing and managing CSV programs compliant with FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. Skilled in validation lifecycle activities is a plus ●Strong knowledge of data privacy regulations including GDPR and HIPAA, with proven ability to develop and enforce compliant data protection policies is a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesResearch Services Referrals increase your chances of interviewing at Cardiovascular Clinical Sciences by 2x Get notified about new Quality Assurance Manager jobs in
Boston, MA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
The following information provides an overview of the skills, qualities, and qualifications needed for this role. Ideal candidates will be local to Boston. Remote candidates able to travel to Boston occasionally will be considered. ●Develop, implement, and maintain the QMS in a state of compliance in accordance with FDA, ICH, ISO, and GxP requirements. Routinely monitor the regulatory environment for changes in regulations and guidelines impacting CCS and incorporating new requirements into CCS processes ●Oversee compliance of CCS’ core business processes. Monitor Key Performance Indicators, clinical program level trends, perform root-cause-analysis (if necessary) and develop action plan to support process improvement ●Serve as the Management Representative for the QMS and conducts Management Review meetings with senior management to discuss and address compliance issues, develop and review quality initiatives in support of continuing process improvement ●Plan and conduct internal and external audits of clinical trial processes, vendors, and documentation ●Host and coordinate regulatory inspections and sponsor audits ●Work directly with Department Heads in the development of new policies, and updating of current procedures and work instructions to ensure the quality of clinical trial process and data ●Oversee and manage change control, document control, deviation handling, and compliance activities ●Deliver and document training for key stakeholders on regulations and standards relevant to clinical research ●Lead the investigation and resolution of quality issues, including Deviations and CAPAs ●Provide QA compliance guidance and support to functions across the organization including Project Management, Clinical Operations, Safety, Biometrics, Core Laboratory and client-related projects ●Collaborate with clinical vendors Qualifications: ●Bachelor’s or advanced degree in life sciences or related field (required) ●7 plus years of Quality Assurance experience preferably in a Contract Research Organization, Pharmaceutical, or Medical Device environment ●Demonstrated leadership in QA; proven auditing and regulatory inspection experience ●Strong interpersonal skills for interactions with internal and external clients ●Able to work independently ●Ability and willingness to travel as needed Knowledge & Skills: ●Strong working knowledge of FDA, ICH, ISO, GxP, pharmaceutical, and medical device regulations for clinical trials Excellent written/oral communications and analytical skills ●Consistently displays a positive, patient attitude and extends respect and courtesy toward Supervisors and peers alike ●Proven organizational, prioritization, and teamwork abilities ●Adept at working independently and collaboratively in fast-paced settings ●Enthusiasm, attention to detail, results-driven, high integrity ●Expertise in Computer System Validation within regulated environments, including developing and managing CSV programs compliant with FDA 21 CFR Part 11, GAMP 5, and EU Annex 11. Skilled in validation lifecycle activities is a plus ●Strong knowledge of data privacy regulations including GDPR and HIPAA, with proven ability to develop and enforce compliant data protection policies is a plus. Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionQuality Assurance IndustriesResearch Services Referrals increase your chances of interviewing at Cardiovascular Clinical Sciences by 2x Get notified about new Quality Assurance Manager jobs in
Boston, MA . We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr