Sr Mgr, Quality Assurance, France

<h4><b>Job Summary</b></h4> <p>Responsible for providing quality leadership, governance, and expertise in Quality Assurance processes related to the manufacture of West products. Ensure compliance to regulatory requirements and West procedures. Proactively develop, lead, and drive the execution of the Quality Assurance strategy. Develop and implement quality assurance plans ensuring compliance with regulations, oversee interactions with regulatory agencies and build strong relationships with internal and external stakeholders. Champion advocacy for product, process, and system quality, and drive continuous improvement within the Quality Management System.</p> <h2><b>Essential Duties and Responsibilities</b></h2> <ul> <li>Cultivate a positive working relationship with internal and external stakeholders by supporting validation in design and development, specification development, and execution of manufacturing programs in line with agreed standards. All the while ensuring that West’s product quality and reliability meets or exceeds customers’ expectations.</li> <li>Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.</li> <li>Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations.</li> <li>Develop strong internal and external relationships with regulatory bodies and authorities.</li> <li>Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.</li> <li>Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.</li> <li>Responsible for developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis</li> <li>Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members.</li> <li>Responsible and accountable for quality departmental budget.</li> <li>Play a role as a key contributor to documentation updating, including leading any updates.</li> <li>Participate in and drive compliance to global harmonization initiatives.</li> <li>Responsible for quality data trending e.g., CAPA, Deviations, Customer Complaints, Product Quality KPI's and Change Requests and driving quality improvements.</li> <li>Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.</li> <li>Acts as a mentor and coach to the business with respect to Quality and Regulatory knowledge.</li> <li>Fosters and encourages shared learning’s across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices.</li> <li>Perform additional duties at the request of the direct supervisor.</li> </ul> <h2><b>Additional Responsibilities</b></h2> <h2><b>Education</b></h2> <ul><li>Bachelor's Degree Preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; required </li></ul><h2><b>Work Experience</b></h2> <ul><li>Minimum 10 years required and</li><li> Previous leadership experience, preferably managing remote employees. preferred and</li><li> Experience in regulated industry such as pharmaceutical and medical device. preferred and</li><li> Project Management experience preferred </li></ul><h2><b>Preferred Knowledge, Skills and Abilities</b></h2> <ul><li>Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other international regulations</li><li>Familiarity with document management databases, particularly MasterControls and SAP.</li><li>Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations</li><li>Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).</li><li>Excellent organizational skills with an ability to think proactively and prioritize work.</li><li>Working knowledge of statistical data analysis</li><li>Thorough understanding of validation activities and risk management principles and techniques</li><li>Strong problem-solving and critical thinking skills</li><li>Medical industry or highly regulated industry</li></ul><h2><b>License and Certifications</b></h2> <h2><b>Travel Requirements</b></h2> 20%: Up to 52 business days per year<h2><b>Physical Requirements</b></h2> Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carr