Facilitate Customer audits by:
- Working directly with the Manager, eClinical Quality Assurance in hosting/facilitating Customer audits.
- Working directly with the Manager, eClinical Quality Assurance in responding to client audit observations.
- Maintaining the QA files/records for Customer audits.
Verifies corporate compliance with regulatory requirements and industry standards through the management of BioClinica's internal audit program by:
- Ensuring internal standards (Policies, SOPs, et al) are in conformity with applicable regulatory agency's regulations and guidance.
- Ensuring, through the conduct of internal audits, that internal standards and staff performance are in compliance with applicable regulatory agency's regulations and guidance
- Conducting internal audits of company policies and procedures
- Conducting audits of any vendors utilized to conduct business.
- Identifying compliance gaps and providing support and suggestions for remediation.
- Coordinating corporate document and media management and archival efforts.
Facilitates the identification and development of Standard Operating Procedures ("SOP") by:
- Working with BioClinica staff to author and revise SOPs and Work Instructions (WIs)
- Providing training and guidance to staff regarding compliance and interpretation of SOPs/WIs.
Assists with the management of various other quality assurance initiatives and programs by:
- Participating in the development and maintenance of quality systems and process improvements
- Leading and investigating quality issues and implementing corrective and preventative actions; identifying departmental strengths and weaknesses
- Supporting the development and implementation of proper document management and change control processes
Maintains continuity among corporate and divisional work teams by:
- Documenting and communicating actions, irregularities and continuing needs
Maintains Quality Service and Departmental Standards by;
- Reading, understanding and adhering to organizational Standard Operating Procedures
- Establishing and enforcing departmental standards
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
- Participating in new hire interviews; facilitating hiring decision
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
- Bachelor's degree required, preferably in life sciences.
- 3+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry
- 3+ years experience in conducting and/or supporting customer/vendor audits.
- 3+ years experience in creating and maintaining SOPs preferred
- Experience with computer validation and/or SDLC methodologies e.g. Agile
- 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
- The ability to interact with department heads regarding corporate compliance
- Ability to maintain professional and positive attitude
- Must be highly motivated and able to influence and motivate others
- Ability to make sound judgments
- Proficient at problem-solving
- Ability to manage multiple tasks effectively & efficiently
- Possess high-level of ethics and integrity
Other: Computer work for long periods of time
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.