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