333 W. San Carlos Street, Suite 800
Job Number: 16026
Bayside Solutions is seeking a Clinical QA Manager to be part of our Client’ s team in the South Bay. This is an opportunity to work with a local organization focused on the movement of new drugs or devices from conception to FDA approval.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join an organization focused on the movement of new drugs or devices from conception to FDA approval.
- Work for a company that is local to the beautiful south bay area.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, vacation/PTO, and 401K.
CLINICAL QA MANAGER
In this position, the Clinical QA Manager (CQA Manager) will provide consultation in the interpretation of GCP regulations, guidelines, policies, and procedures to the staff; plan, conduct, and report independent Good Clinical Practice (GCP) Quality Assurance (QA) audits of internal systems/procedures and the company’ s vendors against applicable regulations and procedures; support, maintain, review QA systems – Controlled Documentation System, Corporate Training program, and Corrective Action and Preventative Actions (CAPAs); and support/provide management with quality metrics and updates.
- Manage the QA Document Control system
- Assist in SOP writing and/or review
- Assist in preparing and hosting Client audits at this company
- Write/Review/Track CAPAs for the company and Client audits
- Conduct audits (internal systems and vendor) for the company
- Provide QA/compliance advice to the company’ s staff
- Perform other related duties as assigned
The Employee shall work well under pressure, and meet multiple and sometimes competing deadlines. The Employee shall at all times demonstrate cooperative behavior with colleagues and supervisors.
- Strong knowledge of FDA GCP and ICH regulations, guidelines, and standards governing regulated clinical research is required.? Working knowledge and understanding of drug development and global clinical regulatory environment
- Outstanding interpersonal, oral and written communication skills.? Detail oriented.? Available to travel 10% of the time.
EDUCATION AND/OR EXPERIENCE:
- Bachelor’ s degree in scientific or related discipline, or equivalent work experience
- Minimum of 5-7 years industry experience, with at least 3-5 years in clinical QA Direct experience with internal/external clinical systems and process audits
- Experience in QA audits of Clinical Investigators and Clinical Vendors
- Experience in development of SOPs
- Strong software and computer skills; including MS Word, Excel, PowerPoint, and Outlook
- Excellent presentation skills
REPORTING STRUCTURE: The CQA Manager will report to the Director of Quality Assurance, a member of the company’ s Core Management Team.
OTHER ORGANIZATIONAL RELATIONSHIPS: The CQA Manager will interface and partner with other Senior Management team members in development of strategy, including being a resource to other departments to improve processes within this company you may also liaise or manage QA contractors or QA vendors.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
- Requires computer work for up to 85% of the work day
- May involve typing at least 4 hours per day
- May involve opening file drawers and inserting or removing files up to 4” thick
- Lifting, moving and set-up of computers and other equipment
- May require lifting, moving, turning, and packing of items greater than 25 lbs