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Associate Director, Quality Assurance GMP

  • Boston, MA
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Company Background

MorphoSys is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. Based on its leading expertise in antibody and protein technologies.
 
Over the last two decades, MorphoSys has forged partnerships with many of the leading global pharmaceutical companies. Together with our global partners, we have developed more than 100 product candidates, of which 27 are currently in clinical development – one of the broadest pipelines in the industry.
 
In 2021, Constellation Pharmaceuticals Inc, became a fully owned subsidiary of Morphosys. Constellation Pharmaceuticals Inc is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics. 
 
Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.com or www.morphosys-us.com or www.constellationpharma.com. We are #BolderAndBrighterTogether!

Job Summary & General Responsibilities

The Associate Director, Quality Assurance GMP is responsible for ensuring adequate quality assurance activities within all GMP and GDP areas at MorphoSys US Inc. The expert role is mainly within Good Manufacturing Practice and Good Distribution Practice however the responsibility in the role includes coordination and support of all GXP activities within the company.
 
In this role, the person will be responsible for ensuring product quality at drug substance and drug product contract manufacturing operations while developing and maintaining relationships. Leading by influence, the individual must be well organized and have excellent oral and written communication skills to effectively interact with external manufacturers to ensure MorphoSys quality compliance needs are met in a timely manner. This includes collaborative interactions such as due diligence, establishing and maintaining quality agreements, review of 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, Validation 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 the Head of US Quality Assurance and will be based in Boston, MA.

Roles and Responsibilities
  • Act as subject matter expert for GMP and GDP related topics
  • Perform batch disposition for commercial product and clinical supplies
  • Coordinate and oversee any stock recovery/recall operation for investigational medical products
  • Maintain relationships with partner CMO's, develop and maintain quality metrics
  • Support technology transfers at CMOs in a Quality role
  • Review of quality event documentation such as Deviation investigations, Change Controls and CAPA
  • 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
  • Review of Product Quality Complaints
  • Attend routine business meetings and external vendor meetings as the Quality representative
  • Represent and support quality-related authority inspections
  • Perform functions and make decisions consistent with cGMPs, GDPs and MorphoSys quality governance
  • Support all aspects of Validation as necessary 
  • Perform routine gap assessment and improve procedures
  • Good understanding of FDA regulations and guidelines
  • Good understanding of CMO mediated Supply Chain activities
  • Excellent organizational, communication, and interpersonal skills

Job Qualifications, Experience & Skills

Qualification:
  • Bachelor’s Degree required, ideally in a scientific discipline. Master’s Degree preferred
  • Sound knowledge in international regulations and guidelines (EU / FDA regulations, ICH etc.)
  • 10+ years of experience in the pharmaceutical, Biologics or health industry with demonstrated knowledge or experience in GMP Compliance
  • Works collaboratively in multi-functional teams as a key player with strong interpersonal and communication skills
  • Excellent documentation skills, e.g., reports, requirements, and specifications
  • Experience with VEEVA or other Quality Management systems (eQMS) is desirable
Health & Safety
Full vaccination against COVID 19 is a requirement for this position.

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.