External Manufacturers Quality Assurance Manager

External Manufacturers Quality Assurance Manager, Global Stability (8493)

**Career Opportunities: External Manufacturers Quality Assurance Manager, Global Stability (8493)**

Requisition ID **8493** - Posted - **EMEA** - **Quality** - **PL-Remote** - City (8)

Bausch Health Companies are part of the fastest-growing international pharmaceutical companies aimed at providing quality products in the field of healthcare. We are focused on fulfilling its commitments to patients, healthcare professionals, shareholders, and society as a whole.

We develop manufacture and offer a wide range of branded and generic pharmaceuticals and medical devices in over 90 countries and regions. Bausch Health products are used every day by over 150 million people worldwide. Our diversified portfolio covers the following therapeutic areas: dermatology, pain, gynecology, urology, gastroenterology, infectious diseases, etc.

**In our global Project Team we are looking for**:
**External Manufacturers Quality Assurance Manager, Global Stability**

**Location: EMEA Region**

**Overview**:
Bausch Health is currently looking to fill a new role for External Manufacturers Quality Assurance Manager, Global Stability (EMQA). EMQA is responsible for ensuring Supply continuity for Bausch Health’s externally manufactured portfolio. The External Manufacturers Quality Assurance Manager, Global Stability will be responsible for administering the global stability program for products manufactured by the external manufacturing network. External Manufacturers Quality Assurance Manager, Global Stability will be managing data gathering, reporting, and other tasks in support of stability studies.

**Key responsibilities**:
The deliverables of the External Manufacturers Quality Assurance Manager, Global Stability within are:

- Managethe Bausch Health stability plan for Global External Manufacturing
- Review and Approve vendor stability protocols prior to stability study initiation.
- Coordinate with external manufacturing partners to assure that annual stability batches are selected for and placed in appropriate stability conditions in a timely manner.
- Coordinate with regulatory, quality, and MS&T scientists to ensure standardized and timely reporting of data based on regulatory reporting schedule needs.
- Review stability data for consistency and compile in central database.
- Provide stability guidance in the implementation of change controls and technical transfers requiring stability studies for Global External Manufacturing organisation.
- Monitor stability results for out-of-trend or out-of-specification to support ongoing investigations as needed and in conjunction with portfolio leads as appropriate.
- Review lot stability tables/analysis as part the vendor publishing of formal product reviews (APRs)/Product Quality Reviews (PQRs).
- In collaboration with Bausch Health Regulatory, ensure stability reports are provided for submission.
- Collection and analysis of periodic stability metrics such as number of ongoing stability studies, stability investigations, AR submission effectiveness, etc.
- Collaboration with Bausch Health External Quality and Contract Manufacturers/Laboratories.
- In conjunction with Material Science and Technology group, manage technical justifications for shelf-life extensions based on provided statistical analysis of stability data.

The following attributes are necessary:

- Bachelor’s degree or equivalent in Chemistry, Master of Science/ Pharmaceutical Chemistry or equivalent academic/vocational training.
- Previous experience performing similar stability coordinating role a bonus but not necessary.
- Operational practice in Medical Device/ Pharmaceutical plant
- Suitable experience that would provide the knowledge, skills, and abilities to perform the job as described.
- Understanding of cGMP is essential. Able to comply with all relevant SOPs and/or internal requirements.
- Must be action oriented, make informed decisions and be self-motivated
- Ability to utilize statistical analysis software is preferred.
- Working knowledge of applied statistics, quality systems and regulatory requirements.
- Ability to detect and resolve problems, own decisions, and accomplish tasks/goals.
- Ability to quickly identify escalation needs.
- Time management, project management and data analytics skills are desired.
- Excellent verbal and written communication skills, detail oriented, and ability to work productively in an interdisciplinary team environment.

**We offer**:

- Contract for indefinite period with 1 year of probation period
- Working in global team
- Pleasant working atmosphere in international environment
- Opportunity for learning and growing in positive and supportive team of professionals

Bausch Health is an EEO/AA employer M/F/D/V.