Job Title: Associate Director Quality Assurance
Job Number: 21748
Location: Boston, MA
Implementing and developing the Pharmaceutical Quality Management System (PQMS) at MorphoSys US Inc. to ensure compliance with FDA/cGMP regulations. Providing support for the MOR US INC´s Quality System components such as vendor audits, training, change control, CAPA, deviations, complaints, recall, batch release, risk management and self-inspections.
- Implementing, continuous monitoring and upgrade of the PQMS at MorphoSys US Inc.
- Preparing metrics and trending data to identify and prioritize continuous improvement opportunities.
- Setting-up internal & external audit program and administration/conduct of respective audits ensuring compliance to FDA regulatory requirements, hosting regulatory authorities during inspections, managing the implementation of SOPs and respective training programs, release of sterile injectable commercial product, implementing and overseeing procedures to ensure distribution sterile injectable commercial product.
- Implementing, continuous monitoring and upgrade of the PQMS at MorphoSys US Inc. Preparing metrics and trending data to identify and prioritize continuous improvement opportunities.
- Implementing and developing the Pharmaceutical Quality Management System (PQMS) at MorphoSys US Inc. to ensure compliance with FDA/cGMP regulations.
- Providing support for the MOR US Inc.’s Quality System components such as vendor audits, training, change control, CAPA, deviations, complaints, recall, batch release, risk management and self-inspections.
- Set-up and ensure continuous improvement of the Quality Management System
- Prepare and perform release of commercial product MOR208 for market in USA
- Plan, perform and follow-up audits of CMOs, Warehouses, Distributors, and preferably PV-vendors
- Host and follow-up authority inspections
- Plan, perform and follow-up self-inspections
- Write, review and approve SOPs
- Review and approve vendor documents
- QA contract for US-authorities and US-based GxP vendors/local contact in case of recall
- Provide support, advice, education and training to other departments/functions involved in oversight of quality related activities
- QA related management and approval of Deviations, Changes occurring at external vendors
- QA related management, approval and follow-up of complaints
- Give input and review yearly Audit Plan and yearly Training Plan (considering GMP/GDP/GVP
- Manage, prepare and follow-up Quality Risk Analysis
- Compile and approve the APR
- Prepare, review and revise Quality Agreements
- Prepare data and reports for the Quality Management Review
- Prepare and submit regular reports for Vice President of Quality
- Close interaction with relevant stakeholders within MorphoSys US Inc. and MorphoSys AG.
- Master Degree preferred; Bachelors is required, in the fields of biology, chemistry or a related life science.
- Must have a minimum of 5 years of professional experience in GMP/GDP Quality Assurance in a pharmaceutical or biotech company in the USA.
- Direct experience interfacing with the FDA is required
- Direct experience working with Third Party Organizations (e.g. CMOs, Distributors, 3PLs, etc. ) is an absolute requirement, including auditing of these kinds of organizations.
- Experience in implementing Pharmaceutical Quality Systems (e.g. writing SOPs, implementing processes)
- Experience in Batch Release is required
- Possess a high level of Integrity
- Ability to be a Strategic thinker
- Ability to have a high level of objectivity
- Excellent presentation skills
- Ability to work effectively across diverse functions and levels in the company
- Ability to lead and motivate teams
- Fluent in English; German and other languages are a plus.