Mapp Biopharmaceutical
  • Carmel, IN, USA
  • Full Time

Pharmaceutical Operations Manager - Quality Assurance

Job #03-18A

Mapp Biopharmaceutical is an innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases.  The Pharaceutical Operations Manager - Quality Assurance works cross-functionally to assure that company-wide activities are performed and maintained in compliance with appropriate standards and regulations.  This person will work with the Vice President of Quality Assurance to assure that all programs are appropriately staffed, quality-related project management deliverables are represented and reporting deliverables are met.   

Basic Qualifications:

  • BS required or MS preferred in biochemistry, chemistry, chemical or process engineering or a similar biological science
  • Minimum of five years in a quality related position as well as five years in a project management position within the pharmaceutical industry
  • Proficiency with project management tools, techniques and processes
  • General knowledge of the requirements associated with GCP, GLP, GCLP and cGMP
  • Experience in supporting GCP, GLP, GCLP or cGMP operations in a pharmaceutical or pharmaceutical-support Company
  • Previous experience in supporting audit planning, execution and completion
  • Experience as a contributor/reviewer of technical protocols, data and final reports
  • Experience as a contributor/reviewer for regulatory documents
  • Experience in conducting risk assessment, root cause analyses, and impact analyses
  • Experience in people management, resource allocation, staffing strategies
  • Familiar with FDA guidance and quality systems
  • Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
  • Excellent record keeping abilities to adequately document process development data

Preferred Qualifications:

  • Experience with US government reporting deliverables and expectations
  • Specific experience with cGMP for biological/parenteral drugs
  • Experience in establishing, maintaining and updating internal Quality policies, procedures and SOPs is an asset
  • Experience with US Government deliverables and expectations


  • Maintains an audit schedule, timing of audits, their completion and timing of responses received
  • Maintains a schedule of quality agreement initiation as well as renewal
  • Tracks the writing, review and approval of Mapp Standard Operating Procedures (SOPs)
  • Maintains a list of all SOPs in the Mapp Quality Management System
  • Serves as process owner for the GxP Individual Training Plan (ITP) process. Works with supervision to ensure that employees' Individual Training Plans (ITP's) are in the appropriate state of readiness
  • Maintains a hard copy as well as electronic copy of all SOPs, training documents, audit reports/responses as well as investigations
  • Serves as the representative from the Quality Assurance Unit to the Project Management team for quality related program resources, scope, schedule as well as budget
  • Ensures that all quality related program deliverables are completed in a timely fashion

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will enjoy a flexible, collaborative and rewarding environment in Carmel, Indiana. Mapp wants you to join their team and invites you to apply.

No Solicitors, agents or placement agencies please. Mapp utilizes E-Verify.

Equal Opportunity/Affirmative Action/Disability/Vets Employer - Applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

Mapp Biopharmaceutical
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