Quality Assurance - Senior Manager, Clinical Quality Assurance - Pennsylvania - Career Opportunities - Sterling-Hoffman Life Sciences - Jobs and Careers in Pharmaceuticals, Bio Technology, Healthcare and Staffing Firm

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Sterling Life Sciences, Specialists in Pharmaceuticals, Healthcare and BioTech Recruitment

Career Opportunities

Senior Manager, Clinical Quality Assurance

Location	Job Id#
Pennsylvania	03664
About our client
Our client produces biological products with a focus on pharmaceutical preparations and research.
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Develop and oversee administration of clinical quality assurance activities including, but not limited to surveillance (e.g., process, system and record audits) 2) Review and approve documents associated with clinical strategy development/deployment and operations (plans, protocols, CRF, CSR, ISE, ISS, etc.) 3) Complete other applicable duties, as business needs dictate and as directed by senior management 4) Serve as the primary quality assurance interface with internal and external customers and partners involved in the development, execution and surveillance of the company's clinical programs 5) Serve as the company's Subject Matter Expert with respect to clinical quality assurance 6) Provide professional guidance and leadership to ensure the company's policies, processes and procedures comply with regulatory and industry best-practices 7) Conduct quality system failure investigations as business needs dictate and report to management 8) Develop, deploy and maintain policies, procedures and guidelines encompassing quality systems supporting Good Manufacturing Practices (GMP) and manufacturing and quality operations 9) Manage Clinical Quality Assurance (CQA) staff (permanent and temporary) 10) Train CQA staff (permanent and temporary) 11) Ensure that the company's' processes, procedures and activities are in compliance with industry standards, GCPs and other current regulations and guidance 12) Investigate and resolve compliance problems and questions regarding regulatory affairs, clinical operations, drug safety, data management, biometrics, risk management and medical affairs 13) Facilitate/organize interdepartmental meetings with Drug Safety, Regulatory Affairs and other departments to maintain awareness of pertinent issues 14) Provide quality-related perspective while promoting thorough communication across departments 15) Organize and/or chair committees related to CQA/compliance issues 16) Develop and maintain policies, SOPs and WPs in compliance with regulatory and industry standards and the company's policies and procedures 17) Perform internal and external compliance audits (e.g., GxP) in accordance with audit plans, applicable regulations and QA SOPs which includes but not limited to, compliance with policies and procedures, databases, clinical study reports, safety summaries, data, tables, Statistical Analysis Plans etc.) 18) Prepare and issue detailed audit reports to appropriate the company personnel outlining compliance issues noted during audits/inspections 19) Support preparation and deployment of associated CAPA plans as well as follow-up to assess progress and verify effectiveness of such plans 20) Participate in site Regulatory Agency Inspections, as business needs dictate, in accordance with the company SOPs 21) Assist in preparing responses to regulatory agency requests when appropriate and conduct quality audits of the data 22) Ensure the quality of internal/external documents (Case Report Forms, Document Completion Guidelines, Protocols, etc.) and/or approve the documents in accordance with internal procedures 23) Develop and maintain training requirements and procedures for the company GxP operations 24) Ensure that the training needs of the company employees are identified, training methods/tools are established and deployed and training records are maintained
Requirements
1) Bachelor's degree in relevant Life Sciences (i.e. Nursing, Biology) 2) Minimum 6 years of experience in clinical compliance areas and/or auditing in GXP compliance in the pharmaceutical industry with at least 3 years direct managerial responsibility 3) Work experience as a Clinical Trial Monitor or experience in the regulatory approval process 4) Thorough knowledge of GCP, GMP, 21 CFR Part 11 regulations and ICH guidelines 5) Excellent leadership skills with a proven record of leading and motivating a dynamic group of skilled professionals 6) Excellent interpersonal and verbal/written communication skills 7) Good organizational, project management and influencing skills 8) Team player with a can-do attitude, the ability to think and implement quickly, and identify creative solutions to complex technical problems 9) Ability to oversee all internal and external audits associated with clinical operations to ensure compliance with GCP and corporate policies and procedures 10) Ability to oversee and develop GxP training programs for the company 11) Ability to work 35 – 45/hr in a temporary or permanent position

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