Sr GCP Auditor / Clinical QA investigator (remote / telecommute) at Boston

Job Description

Title- Sr GCP Auditor / Clinical QA investigator (remote / telecommute)

 

A growing, large cap pharmaceutical company is hiring.  With over 21,00 employees working in over 170 countries the firm is focused on developing more effective treatments for areas of unmet healthcare needs that can have a major impacts on patients’ lives.

A compelling new product pipeline, including several promising late-stage programs with significant potential along with strong revenue growth from exiting products lend towards long term financial stability.

 

Revenue growth is currently beating the market’s expectations in 2013.  Worldwide pharma sales were up over 8% in 2012 and 2013 is tracking similar growth.

The pipeline includes 4 new approvals in 2012 and is showing considerable promise with late stage candidates in hepatitis C, immunology, multiple sclerosis, endometriosis, diabetic kidney disease, multiple myeloma, and Parkinsons disease.

 

The company possesses a streamlined and efficient regulatory execution process which allows for smooth advancement of the pipeline and fast approval of new indications for commercial products.  Current goals are to obtain 15 major regulatory approvals between 2013 and 2017. 

 

Remote + travel (40%)

 

Job Description:

1. Assure that global pharma development remains in compliance with Corporate policies and procedures and all applicable worldwide regulations during the execution of pharmaceutical clinical trials;

2. Assess the success and effectiveness of the global pharma development quality system by leading compliance audits and applicable assessments (e.g. PAI readiness assessments);

3. Provide consultation and assistance to global pharma development personnel on compliance issues.

4. Assist in regulatory inspections;

Provide global pharma development personnel with training on applicable worldwide regulations; Lead cross-functional project teams to help resolve issues.

Major Responsibilities:

1. Interpret, explain and apply the applicable current regulations, guidelines, policies and procedures;

2. Plan, organize, and lead multiple audits of R&D facilities, equipment, personnel, methods, practices, computer systems, procedures, records and controls for compliance to protocols, policies, SOPs, and applicable governmental regulations globally;

3. Plan, organize and lead multiple audits of investigative clinical sites to assess compliance with regulations, guidelines, policies, procedures and sponsor requirements;

4. Review a variety of clinical research documents such as protocols and research reports to assess the quality and compliance to policies, procedures, and applicable governmental regulations;

5. Evaluate the potential risk of compliance deficiencies;

6. Plan, organize and lead audits of external contract facilities (specialty testing laboratories, central laboratories, clinical sites, central Institutional Review Boards (IRBs), Contract Research Organizations and distributors as applicable) both within the US and globally;

7. Maintain effective communication of project related information;

8. Review corrective action plans/audit responses for adequacy and approve if adequate;

9. Review policies and procedures and suggest improvements;

10. Create quality/compliance training programs for the global development organization;

11. Initiate, manage, and/or participate in quality improvement projects

12. Work independently as well as a team;

13. Mentor, coach and train QA auditing staff;

14. Prepare and present project progress reports to update management and keep the team(s) informed;

15. Lead/assist/manage external audits by regulatory agencies or customers;

Job Requirements

Required Experience:

• Previous experience in QA/RA preferred or experience in clinical research development 5-7yrs
• Pharmaceutical Industry 5-7 yrs
• QA Auditing Experience (GCP Auditing Preferred) 3-5 yrs
• Total combined minimum years experience preferred 7 yrs

 

The Individual must be able to:

• Work independently, in a team environment, and with all levels of personnel within the organization;
• Effectively handle multiple assignments simultaneously;
• Anticipate and adjust to rapidly changing priorities and anticipate the impact of the change on overall project(s).
• Demonstrate a thorough knowledge of the applicable regulations and be able to apply them to a wide variety of situations
• Successfully interact with all levels of personnel within the division.
• Take initiative and identify new approaches to resolve problems (i.e., risk assessments, CAPA plans).
• Utilize innovation in solving problems.

 

Core competencies:

CQA, certified quality auditor, Clinical research, clinical trials, biotechnology, biologics, pharmaceutical auditing, inspection, investigations, clinical sites, vendors, audit scheduling, facilities audits, equipment audits, personnel audits, methods audits, audit practices, computer systems audits, procedure audits, records audits, change controls, documentation audits, CAPA, quality systems, audit reports, technical writing

Country: USA, State: Massachusetts, City: Boston, Company: MR - Klein Hersh International.