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Associate Director, QA Technical Services Lead
2 months ago
At bioMerieux Inc., we are seeking an experienced Associate Director to lead our Quality Assurance Technical Services team. As a key member of our organization, you will be responsible for developing and implementing practical, innovative, and sustainable quality systems and approaches.
Key Responsibilities:- Lead a team of quality engineers and validation engineers to provide guidance for investigations, recommend solutions using risk-based techniques, and perform testing protocols to verify changes adequately mitigate identified risks.
- Drive reduction of the cost of poor quality through lower scrap rates, reduced rework, and more effective process control.
- Promote compliance improvement through education, strategic project initiatives, and organizing compliance activities.
- Manage validation activities, validation of site continuous improvement projects, and validation activities defined in the Site Master Validation Plan.
- Implement continuous improvement activities associated with the validation program and own the Validation Quality System as defined by site, regional, and/or global procedures.
- Bachelor's Degree in a technical or science-related field with a minimum of ten (10) years of experience in a regulated industry with five (5) years of experience in quality or validation work.
- Five (5)+ years of experience managing large groups is highly preferred.
- Must possess a thorough understanding of cGMPs, FDA validation requirements, ISO, and MDSAP standards and regulations.
- Requires excellent written and oral communication skills to interact across all levels of the organization.
- Requires expert skillset of risk analysis, problem-solving, statistical methods, and detail-oriented technical writing.
- Must have experience leading people, projects, and teams with the ability to work with limited supervision and to take initiative to ensure timely completion of tasks.
- Extremely detail-oriented with strong organizational skills and high-quality standards.
- Excellent relationship-building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change and driving the adoption of new processes from a position of indirect or informal authority.
At bioMerieux Inc., we offer a dynamic and challenging work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
We are an equal opportunity employer and welcome applications from diverse candidates. Please note that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant's identity and legal authorization to work in the United States are required of all new hires.
bioMerieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.
