Associate Director, Quality Operations

Position Summary

The Associate Director, Quality Operations is responsible for ensuring quality assurance activities within all GMP areas at MorphoSys US Inc. and Constellation. This role is mainly within Good Manufacturing Practice and Good Distribution Practice however the responsibility in the role includes coordination and support of GXP activities within the company.

In this role, the person will be responsible for providing quality oversight of drug substance and drug product contract manufacturing operations while developing and maintaining relationships. Lead by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with external manufacturers and internal stakeholders to ensure MorphoSys and Constellation quality compliance needs are met in a timely manner. This includes collaborative interactions such as review of batch records, change controls, deviations, CAPA and metrics as well as providing support to build effective quality systems and supporting continuous improvement activities. This individual will work closely with CMOs, CMC, Regulatory, Quality Systems, and Supply Chain Operations teams to maintain drug product supply.

This position supports Quality Assurance activities to assure quality and compliance with GMP regulations, internal policies, procedures and best industry practices. This position will report to Quality Operations.

• Support drug substance and drug product validation including review of Protocols, Risk Assessments and Reports
• Attend routine business meetings and external vendor meetings as the Quality representative
• Approve quality events such as Deviation investigations, OOS investigations, Change Controls and CAPAs
• Support Inspection Readiness and Healthy Authority Inspections.
• Act as subject matter expert for Quality on GMP related topics
• Perform batch disposition of clinical and commercial products
• Support Product Quality Complaint Review and Recalls
• Perform functions and make decisions consistent with cGMPs, GDPs and internal quality governance
• Review and approve external vendor GMP documents which include but are not limited to drug substance and drug product batch records, packaging and labeling records
• Create and approve Quality Technical Agreements

Minimum Education/Skills/Experience

• Work collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
• Excellent documentation skills, e.g., reports, presentations, etc.
• Strong knowledge in international regulations and guidelines (EU / FDA regulations, ICH etc.)
• Bachelor's Degree required, ideally in a scientific discipline.
• Excellent organizational, communication, and interpersonal skills
• 10+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GMP Compliance

Preferred (But Not Required)

• Experience with electronic Quality Management Systems (eQMS) is desirable
• Experience in drug product manufacturing, analytical or contract manufacturing is desirable
• Experience with clinical and commercial manufacturing is desirable

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 flex time off program 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.

Health and Safety

Full vaccination against COVID 19 is a requirement for this position.

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.

Reasonable Accommodations

MorphoSys is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, you may contact us at [email protected]