Position Summary

Associate Director, Clinical Quality Assurance / GCP QA at Constellation will be responsible for providing leadership and direction for ongoing clinical projects, cross-functional teams, and at management review meetings on Good Clinical Practice (GCP) related activities/issues, and act as a GCP expert. This position will also be responsible for driving process improvements and providing expertise and consultative guidance on GxP business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities. Telecommuting permitted from anywhere within continental U.S.

Job Duties:

• Develop and implement Good Clinical Practice (GCP) / Good Pharmacovigilance Practice (GVP) / Good Laboratory Practice (GLP) compliance risk-based audit strategies and master audit plans; includes the management, planning, conduct, approval, and close-out of audits (e.g. for a specific clinical development drug program(s) or subtype of audit), if applicable, working closely with Contract Research Organization personnel or consultants to prepare, conduct and report outsourced audits;
• Thoroughly manage audits in Veeva; manage business relationships with stakeholder groups and senior leaders;
• Provide subject matter expertise and participate in the development and review of Governing Documents (policies, SOPs, etc.) related to the Quality Management System (QMS), including audits, Corrective and Preventive Action (CAPA) and Quality Issue management, regulatory inspections, and quality risk management;
• Participate in Protocol Deviations review meetings and Risk Review to identify trend analysis and make recommendations;
• Participate in vendor management (e.g. qualification, requalification and implement quality agreements);
• Contribute to the Protocol Review Committee meetings for protocol review/ participate in protocol review within cross-functional teams;
• Lead/contribute to Inspection Readiness and inspection execution activities and act as primary point of contact for clinical site inspection readiness, clinical site inspection support, and sponsor inspection support; inspection readiness may be applicable for regulatory agencies and health authorities pertaining to GCP/GVP/GLP, including liaising with vendors to ensure their compliance and inspection readiness;
• Liaise with respective internal functions to assess job role training requirements and participate in the development and execution of GCP/GVP governing documents and related training; conduct internal trainings related to GCP as required; and
• Maintain an in-depth understanding of business principles, industry trends, and the regulatory environment related to GxP activities.
• If telecommuting, travel required (approx. 10%) to Constellation’s headquarters in Boston, MA.

Associate Director, Clinical Quality Assurance / GCP QA will report directly to MorphoSys’ Group Leader GCP/GVP/GLP based in Germany and indirectly to MorphoSys’ Head of Global Quality Operations.

Minimum Education/Skills/Experience

• Bachelor’s degree in Biotechnology, Regulatory Science, Pharmaceutics or Pharmaceutical Science or Industrial Pharmacy (or its foreign equivalent); plus 8 years of quality assurance experience within the pharmaceutical drug development industry as a Quality Assurance Manager, Lead, Specialist or Associate;

OR

• Master’s degree in Biotechnology, Regulatory Science, Pharmaceutics or Pharmaceutical Science or Industrial Pharmacy (or its foreign equivalent); plus 6 years of quality assurance experience within the pharmaceutical drug development industry as a Quality Assurance Manager, Lead, Specialist or Associate;

AND EXPERIENCE MUST INCLUDE THE FOLLOWING, WHICH MAY HAVE BEEN GAINED CONCURRENTLY:

• 8 years of experience within a pharmaceutical drug development GCP-related discipline (such as clinical site and CRO auditing; CAPA and Quality management, training, and records management; or Governing Document development and implementation);
• 4 years of project management experience;
• Advanced knowledge of FDA, EMA, and GCP/GLP/GVP/ICH regulations and guidelines applicable for clinical trials conduct and/or regulated drug development activities, including general compliance and audit concepts; and
• Excellent verbal and written communication skills.

Culture & Benefits

As a full time, employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment, and we believe the unique contributions each of us brings drives our success

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.