For The Candidates

Location:  Rockville, MD

Applicants must meet the following requirements:

• Bachelors or Masters degree in the life sciences preferred plus relevant work experience required.
• Minimum of 7 years pharmaceutical/biotech research experience with at least 5 years of GCP auditing experience, and at least 3 years management experience; or equivalent combination of education and experience.
• Experience with international clinical trials and 21 CFR Part 11 is required.
• Previous supervisory experience required.
• In-depth knowledge and application of FDA and ICH GCP regulations, guidelines and industry practices and the ability to interpret the regulations/guidelines.
• Ability to read, analyze and interpret scientific and technical journals, as well as regulatory documents.
• Ability to respond to inquiries or complaints from regulatory agencies. 
• Ability to effectively present information to management, regulatory agencies and other departments.
• Ability to write audit reports.
• Strong knowledge of MS Word, Excel, PowerPoint & Outlook. 
• Excellent interpersonal, communication, analytical, managerial, and organizational skills.
• Demonstrated ability to work independently and take initiative.
• Experienced in GCP training.
• Working knowledge of GLPs, and/or GMPs guidelines/regulations is a plus.
• Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
• Must be able to handle multiple priorities at once and be willing to travel.

The selected candidate will be responsible for:

• Developing and overseeing execution of companies audit plans/strategies.
• Processing and evaluating audit findings to monitor overall compliance and to identify quality related trends/issues, areas of business and/or regulatory risk, and training needs.
• Conducting and/or managing systems audits of the companies systems and processes.
• Assisting functional areas in developing and implementing processes, procedures, and systems to perform critical activities in an efficient and effective manner to assure compliance with applicable regulations and company standards.
• Providing consultation on regulatory compliance issues to MG Project Teams.
• Providing computer validation guidance and auditing for regulatory compliance.
• Developing and conducting training programs in all aspects of GCP and SOPs.
• Traveling up to 25% of the time for audits and training. 
• Managing and developing direct report(s).

• Performing other Clinical QA duties as necessary.  

Benefits:  Competitive salary and benefits package