US-MD-Gaithersburg: Senior Director QA Supplier
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please visit http://sqa.fyicenter.com
Senior Director QA Supplier
Requirements/Qualifications: The role holder requires a breadth of knowledge of Quality Assurance, Manufacturing, Supply Chain, Project and Technical management to meet the business targets and ensure compliance with regulatory, quality and safety standards.
Comprehensive understanding of their own function, as well as a strong understanding of other related functions and how they interface to secure product flow.
The role requires a good working knowledge of the pharmaceutical manufacturing industry as the role holder will be required to keep up to date with developments in areas such as GMP standards, external regulatory requirements, best practice and ensure that industry standards are applied to manufacturing and team working.
Position Requirements Special Skills/Abilities: The job holder is required to negotiate, persuade and influence others both within own team, the operating unit, and cross functionally. As a result of this, the role requires a high level of professional and effective interactive communication skills required.
Problem management that requires evaluative judgements based on the in-depth analysis of factual and qualitative information in complicated or novel situations.
Other key competencies include:
- Conceptual thinking
- Contributes to change agenda and leads change
- Conflict resolution
- Risk management
- Adaptive leadership style
- Personal resilience/Emotional intelligence
- Understanding of Supply Chain capability – minimum requirement
- Understanding of Lean manufacture – minimum requirement
- IT literate with awareness of advances relevant to own area and information management requirements
- Proven & Experienced Leader
- Ability to interact and influence at all levels of the organization
Educational Requirements Education: BS. Engineering, Biology, Chemistry or related field
MS. Management, MBA or related field
- 15 plus years of experience in an operational environment. Biopharmaceutical, Pharmaceutical, Vaccines & Protein products experience preferred.
- Extensive experience leading and managing external suppliers for the manufacturing of Biopharmaceutical and Pharmaceutical products including Raw Material suppliers, Off-site testing labs and Contract Manufacturing Organizations.
- Extensive Experience in Quality & Supply Chain Operations
- Track record of successfully leading, influencing and working cross-functionally and at all levels of the organization
- Enterprise & strategic focus
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Team SQAFYI - Software QA Resource FYI