Employment

Title of Position:  Manager, Clinical QA

Job Code #08033

Location:  Rockville, MD

Applicants must meet the following requirements:

• Bachelors degree or Masters degree, preferably in the life sciences
• Minimum  of seven years pharmaceutical/biotech research experience with at least five years of GCP auditing experience and at least three years of management 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:

• Develop and oversee execution of MacroGenics, Inc. audit plans/strategies.
• Process and evaluate audit findings to monitor overall compliance and to identify quality related trends/issues, areas of business and/or regulatory risk, and training needs.
• Conduct and/or manage systems audits of MacroGenics systems and processes.
• Assist 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.
• Provide consultation on regulatory compliance issues to MG Project Teams.
• Provide computer validation guidance and auditing for regulatory compliance.
• Develop and conduct training programs in all aspects of GCP and SOPs.
• Travel up to 25% of the time for audits and training. 
• Manage and develop direct report(s).
• Perform other Clinical QA duties as necessary.

Benefits:  Competitive salary and benefits package

Qualified applicants with current permission to work in the United States, please send your resume and salary history to:

Human Resources 
MacroGenics, Inc.
1500 East Gude Drive
Rockville, MD 20850
E-mail:  HResources@macrogenics.com

MacroGenics, Inc is an Equal Opportunity Employer.