Mapp Biopharmaceutical
  • San Diego, CA, USA
  • Full Time


Vice President of Quality Assurance

Job #21-37R


Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, 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, and in support of biodefense programs.

The Early Research and Development Group (ER&DG) and the Advanced Research and Development Group (AR&DG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of robust portfolio with the CMC, Preclinical/Nonclinical (together, "Nonclinical"), Regulatory and Clinical development goals consistent with the product development objectives of Mapp.

The Vice President of Quality is responsible for oversight of an existing Quality Assurance (QA) department that operates virtually. The VP is a key-member of the leadership team to develop and execute the quality-related corporate goals and objectives for the company. The position is responsible for leading the Quality Assurance activities at the company as a clinical and commercial manufacturing organization. The VP is responsible for oversight of the quality systems and assuring the overall GCP, GLP and GMP compliance with current regulatory requirements and guidelines.

Basic Qualifications:

  • PhD degree in a scientific related discipline
  • 15+ years of experience in biotech and/or pharmaceutical manufacturing
  • 10+ years of experience in quality operations (QA, QC and/or Validation within biotech and/or pharmaceutical industry)
  • Experience supporting regulatory filings (e.g., INDs, BLAs, MMs, etc) and leading product-related inspections for US and foreign regulatory agencies
  • Experience developing, implementing and executing strategic plans and objectives for organizations and departments
  • Exceptional customer interface skills
  • Ability to negotiate and achieve alignment with executive management and external audiences at the highest levels, including regulatory agencies

Responsibilities

  • Provides leadership and direction to the Quality organization
  • Provides mentorship, oversight and development for the Quality Assurance and Quality Operations staff
  • Directs and controls the activities and outcomes of Quality Assurance which has a significant organizational impact
  • Accountable for vendor adherence to all applicable quality regulations
  • Serves as an active member of the Leadership Team responsible for development and setting of company Quality and Quality-related strategy and goals
  • Holds final accountability for and decision-making on the matters relating to GxP compliance for the company
  • Makes decisions focused on key quality- strategic and operational matters that have significant, direction-setting impact on the overall company
  • Sets and aligns goals and objectives for the Quality Assurance department with the overall corporate goals and objectives
  • Ensures that the quality-related goals and objectives are accomplished
  • Accountable for Quality Assurance departmental staffing and must be comfortable supervising and operating in a virtual organization
  • Provides advice to the Leadership Team on regulatory GxP compliance issues
  • Serves as the principal spokesman with customers, regulatory agencies, etc., on matters of regulatory GXP compliance
  • Works with all Mapp employees to align and integrate quality systems

Mapp offers a competitive compensation and benefits package in addition to this exciting and challenging job. You will have the opportunity to work in Mapp's new state-of-the-art San Diego facility, or, if your job responsibilities allow, you may choose to work remotely (outside of the State of Colorado). Willingness to Travel ~<30% - Domestic + ~<10% - International Travel will be required for this position.

Mapp wants you to join their team and invites you to apply by submitting your information through https://mappbio.applicantpro.com/jobs/.

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

Mapp is an Equal Opportunity/Affirmative Action/Disability/Veterans Employer - Qualified 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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