Primary ResponsibilitiesGoverns Systems Software Quality by:
- Working directly with BioClinica eClinical development teams to ensure the accuracy and consistency of system development deliverables.
- Authoring, supporting and/or maintaining software quality (Validation) documentation for BioClinica developed, managed, and/or purchased systems. This includes, but is not limited to, system Risk Assessments, Computer Validation Plans, Test Plans, Test Reports, Requirement Specifications, Release Memos and Validation Summary Reports.
- Execution and approval of software quality (Validation) documentation.
- Fostering system quality knowledge both for development teams as well as the rest of BioClinica's eClinical division.
- Reporting results and reviewing anomalies, as appropriate, to the Director, eClinical Quality Assurance.
- Supporting the development and implementation of proper document management and change control processes relating to system development and Validation.
Facilitates the identification and development of Standard Operating Procedures ("SOP") by:
- Assisting with the writing, revising, and reviewing of software develop SOPs.
- Providing training and guidance to staff regarding compliance and interpretation of SOPs.
Performs supervisory functions by
- Communicating job expectations
- Planning, monitoring and appraising job results
- Mentoring, counseling and disciplining staff
- Identifying and developing key staff to eventually assume greater responsibility and growth within the company
- Initiating, coordinating and enforcing systems, policies and procedures
- Approving direct reports time sheets, requests for time off and/or overtime
- Performing timely performance evaluations of direct reports
- Coordinating and conducting new hire interviews; facilitating hiring decision
- Training new hires on departmental processes and responsibilities
Secondary ResponsibilitiesAssists with the management of other quality assurance initiatives and programs by:
- Assisting with the development and enhancement of quality processes to promote, facilitate and ensure compliance with all regulatory and company standards.
- Participating in the development and maintenance of quality systems and process improvements.
- Leading and investigating quality issues and implementing corrective actions; identifying departmental strengths and weaknesses.
Contributes to team effort by:
- Exploring new opportunities to add value to organization and departmental processes
- Helping others to accomplish results
- Performing other duties as assigned
Maintains Professional and Technical Knowledge by:
- Attending and participating in applicable company sponsored training
- Attending educational workshops and reviewing professional publications
- Benchmarking state-of-the-art practices
- Participating in professional societies
- Keeping informed of changes in the regulatory environment and/or regulatory requirements
Qualifications:Education:
- Bachelor's degree in life sciences, regulatory affairs or similar field required
- Advanced degree preferred
Experience:
- 5+ years current experience in a Validation or other Quality role within the pharmaceutical industry
- 2+ years management experience in clinical development within the pharmaceutical industry preferred
- 3+ years experience in creating and maintaining SOPs preferred
- Demonstrated above average written communication skills in the English language
- Proven ability to work with and direct teams to accomplish goals
- Must be familiar with US and EU regulations and guidance
Additional skill set:
- Strong interpersonal and communication skills, both verbal and written
- Strong organizational and leadership skills
- Goal oriented
- The ability to interact with department heads regarding corporate compliance
- Ability to maintain professional and positive attitude
- Must be highly motivated and able influence and motivate others
- Ability to make sound judgments
- Proficient at problem-solving
- Ability to manage multiple tasks effectively & efficiently
- Possess high-level ethics and integrity
Working conditions:Travel: 0-25%
Lifting: 0-25lbs
Other: Computer work for long periods of time
