Associate Director, Quality Assurance GMP/GDP

    Boston, MA, US
470 Atlantic Avenue, 14th Floor
MA 02210 Boston, MA
Vereinigte Staaten

Company Background

MorphoSys is dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from serious diseases, with a focus on cancer. Living up to the origin of our name - Metamorphosis - we have embarked on an ambitious transformation from a leading R&D company to a fully integrated biopharmaceutical company with an approval for a breakthrough cancer therapy.

Over the last two decades, MorphoSys 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.
 
Headquartered in Planegg, near Munich, Germany, MorphoSys, including the fully owned U.S. subsidiary MorphoSys US Inc. in Boston, MA, has 600+ employees.
 
Learn MOR at www.morphosys.com or www.morphosys-us.com.

Job Summary & General Responsibilities

The Quality Assurance Associate Director GMP/GDP 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 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 chain operations teams to maintain drug product supply.
 
This position supports Quality Assurance activities to assure quality and compliance with 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
  • Coordinate and oversee any recall operation for medical products
  • Maintaining relationships with partner CMO's, developing and maintaining quality metrics.
  • Support technology transfers at CMOs in a quality role
  • Review of event documentation such as Deviation investigations, Change Controls and CAPA
  • Attend routine business meetings as the quality representative
  • Represent and support quality-related authority inspections
  • Perform functions and makes decision 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 is desirable
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