上海招聘

Primary Responsibilities

Designs, develops, implements, leads and manages all internal audit programs by

• Managing internal audits as requested by senior management or the department head
• Auditing systems and staff competency for overall facility compliance to FDA requirements
• Participating in the development and maintenance of all quality systems and process improvements

• Leading and investigating quality issues and implementing corrective actions; identifying departmental strengths and weaknesses
• Developing and implementing proper document management and change control processes
• Providing regulatory guidance to management team

Facilitates the identification and development of Standard Operating Procedures (“SOP”) by:

• Assist with the writing, revising, reviewing and approving of all SOPs
• Providing training and guidance to staff regarding compliance and interpretation of  SOPs

Assists with the management of various other quality assurance initiatives and programs by:

• Assist with the development and enhancement of quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by
• Assists with the writing, revising, reviewing and approving of all Standard Operating Procedures (“SOP”)
• Participating in the development and maintenance of all quality systems and process improvements
• Leading and investigating quality issues and implementing corrective 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

Secondary Responsibilities

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

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 required, preferably in life sciences.  Advanced degree preferred

Experience:

• 3+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry
• 3+ 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, both verbal and written
• Strong organizational and leadership skills
• Goal oriented
• Ability to maintain professional and positive attitude

Working conditions:

Travel:  0-15%

Lifting:  0-25lbs

Other:  Computer work for long periods of time

EEO Statement

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

BioClinica, Inc provides our clinical trial sponsors best-in-class centralized cardiac safety & efficacy services and independent medical image assessment solutions; all designed to facilitate successful new drug development in the pharmaceutical, biotechnology and medical device market sectors.
Built on over 27+ years of cumulative clinical research experience, BioClinica offers the world-wide biopharmaceutical industry unparalleled service quality, dedicated global capabilities and advanced technologies boasting a 100% on-time delivery of all projects. With a sustainable track record of medical and regulatory expertise, market leadership and proven operational processes, sponsors turn to BioClinica for trial design consultation and customized service offerings tailored specific to their unique needs.
BioClinica's extensive international experience is comprised of working alongside a broad spectrum of organizations across 600+ studies - Phase I - IV in over 60 countries around the globe. Our market leading medical imaging services are proven across more oncology trials than any other core laboratory. Our imaging and cardiac safety solutions are performed in a stringent quality controlled environment, ensuring GCP and 21 CFR Part 11 compliance.
We believe our employees are one of our greatest assets and we strive to attract and retain the highest caliber, professionally skilled and dedicated staff. If you are interested in making a difference in the quality of people's lives and working in an exciting environment that offers excellent compensation and benefits, then BioClinica is interested in you.