Sr Mgr Supplier Quality

il y a 2 jours

Beerse, Belgique Johnson & Johnson Temps plein

**Job Function**:
Quality
**Job Sub Function**:
Supplier Quality
**Job Category**:
Professional
**All Job Posting Locations**:
Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy, Leiden, South Holland, Netherlands, Little Island, Cork, Ireland, Ringaskiddy, Cork, Ireland, Schaffhausen, Switzerland

**Responsibilities**
- Directs Quality and Compliance activities of external manufacturing mainly in EMEA region for ECSQ Advanced Therapeutics projects and provides the proper interface to DPDS.
- Provides leadership in the selection, management and development of external manufacturers for DPDS in the region and is the quality SPOC for selection of new product launch sites externally in support of JSC sourcing committee.
- Provides leadership in selection of new employees and direct reports in the regions and make sure resource planning is executed.
- Is the ECSQ SPOC (single point of contact) for new BioTD/New Modalities projects and issue management.
- Leads audits of suppliers and leads the development of corrective action plans and monitors implementation.
- Drives the development, writing and implementation of quality procedures. Provides QA support for technology transfer and improvement of existing manufacturing processes.
- Contributes to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products.
- Conducts investigations, performs customary audits, collects data, analyzes trends, and prepares reports as required.
- Leads a team that is responsible for the quality management oversight of external manufacturers supporting DPDS in EMEA. Acts as a coach and mentor for other Managers and Associates in ECSQ and DPDS.
- Escalates issues as appropriate to Senior Management and supports the Executive Management Reviews.
- Works closely with External Supply Integration and other Quality Assurance functions.

**Minimum Qualification**
- Bachelor’s Degree with a minimum of 12 years in an EMA/FDA regulated environment is required; preferably in a pharmaceutical / biologics manufacturing or quality environment. Advanced degrees are a plus and may reduce the experience required.
- Extensive knowledge of Quality Assurance, Quality Control and Compliance.
- Significant experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred.
- Shows ability to provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues is required. Basic Principles of Aseptic Processing is preferred.
- Experience investigating customer Product Quality Complaints is preferred.
- Position requires a minimum of 30% travel to external manufacturing sites.
- Demonstrates mature skills in the following Global Leadership areas:

- Integrity and Credo Based Actions;
- Strategic Thinking; Big Picture Orientation with Attention to Detail;
- Intellectual Curiosity;
- Sense of Urgency;
- Results and Performance Driven;
- Collaboration and Teaming;
- Prudent Risk Taking;
- Self Awareness and Adaptability

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