Associate Director, Quality Assurance GMP

Boston, MA

About Us

At MorphoSys, we are driven by our mission: More life for people with cancer. As a global commercial-stage biopharmaceutical company, we develop and deliver innovative medicines, aspiring to redefine how cancer is treated.

Living up to the origin of our name – Metamorphosis – we transformed from a leading R&D partner into a fully integrated biopharmaceutical company. After nearly three decades in Germany, the doors to MorphoSys US opened in 2019 in Boston to launch our first breakthrough cancer immunotherapy, MONJUVI® (tafasitimab-cxix) in relapsed / refractory diffuse large B-cell lymphoma (DLBCL).

Since then, we haven’t slowed down. Adding to our leading R&D capabilities in Germany, a second global development hub opened in Boston to accelerate our US Commercial capabilities. In 2021, we expanded our portfolio with the acquisition of Constellation Pharmaceuticals, and we are continuing to emerge as a leader and future powerhouse in hematology-oncology. Grow with us.

MorphoSys is headquartered in Planegg, German and has its U.S. operations anchored in Boston, Massachusetts, offering colleagues flexible work models in all locations. The MorphoSys Group has more than 500 employees. For more information, visit www.MorphoSys.com and follow us on LinkedIn and Twitter.

Position Summary

Associate Director, Quality Assurance GMP at MorphoSys US will be responsible for ensuring adequate quality assurance activities within all GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) areas at MorphoSys, including coordination and support of all GxP (Good Practice) activities within the global company. This role will be responsible for ensuring product quality at drug substance and drug product contract manufacturing operations while developing and maintaining relationships, and will involve working closely with MorphoSys CMOs, External Supply Operations, Regulatory, Quality Systems & Compliance, Validation and Supply Chain teams to maintain drug product supply. 

Associate Director, Quality Assurance GMP at MorphoSys US will report directly to MorphoSys’ Head of Global QA Operations.

Job Duties:

  • Provide Quality Assurance operational support to MorphoSys’ cross-functional teams to ensure quality and compliance of clinical and commercial products with GMP and GDP regulations, internal policies, procedures and best industry practices;
  • Act as subject matter expert for GMP and GDP related topics;
  • Perform batch disposition of commercial product and clinical batches;
  • Approve clinical and commercial product quality events, such as deviations, investigations, change controls and CAPAs (corrective action and preventive action);
  • Review GMP Quality Technical Agreements (QTA);
  • Perform internal and external audits and manage GMP internal audit schedule;
  • Maintain relationships with partner’s, CMO's, and third-party logistics/distribution facilities;
  • Support technology transfers at CMOs in a Quality role;
  • Review and approve external vendor GMP documents, including but not limited to, drug substance and drug product batch records, packaging and labeling records;
  • Review of product quality complaints;
  • Attend routine business meetings and external vendor meetings as a Quality representative;
  • Support Quality during health authority inspections;
  • Perform functions and make decisions consistent with cGMPs, GDPs and MorphoSys quality governance;
  • Perform process improvements, Lean initiatives and updates to Standard Operating Procedures as required; and
  • Support validation as necessary. 

Minimum Education/Skills/Experience

  • Bachelor’s degree in Biology, Chemistry, Biochemistry, Pharmacy or Pharmaceutical Science, or a related life sciences field, plus
  • 10 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role;

 OR

  • Master’s degree in Biology, Chemistry, Biochemistry, Pharmacy or Pharmaceutical Science, or a related life sciences field, plus
  • 8 years of GMP quality assurance experience in the pharmaceutical, biologics or health industry as Quality Assurance Manager, Lead, Specialist or similar role;

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

  • At least 3 years of experience with Batch record review, Batch disposition, deviation investigations and CAPA tracking;
  • Experience with internal and/or external GMP audits;
  • Experience preparing, reviewing and approving internal and external documents used in GMP activities, such as batch records, stability protocols and reports, specifications, deviations, and change controls;
  • Strong knowledge of applicable FDA, EU, and ICH regulations and guidelines;
  • Experience usings electronic Quality Management Systems (eQMS);
  • Strong understanding of supply chain and distribution activities; 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.