Job Description Summary

Provide leadership and management of the site laboratories (e.g., Microbiology, Chemistry) including sterility assurance, production support and environmental monitoring in support of production operation.

Job Description

Key Responsibilities:

- Manage and/or oversee the work of assigned team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities on on-going projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, department budget, the development and validation of laboratory test methods in support of production and/or new product/process development. Overall leadership in ensuring Lab processes/personnel complies with pertinent Laboratory Environmental and Safety regulations.

-Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups

- Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines

- Develop a robust talent development plan in alignment with functional growth strategies of the department including meeting the needs of the organization and customers and to better understand core competencies

- Lead in the development, monitoring and publishing of appropriate metrics for the organization

- Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external stakeholders. Develop strategies and address trends and issues within own area including risk management

-May actively participate in the EW Global Laboratory council to help drive consistency and improvement and lead initiatives across laboratory network.

- Other incidental duties: Participate in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma). Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements.

Education and Experience:

- Bachelor's Degree in related scientific field chemistry, biology or microbiology, required.

-Related experience within applicable regulated laboratory, required.

- Experience in Quality management in the medical device, pharmaceutical industry, or the equivalent, required.

- Demonstrated track record in effective laboratory management, including compliance, technical excellence, and organizational development, required.

Required skills:

- Proven successful project management leadership skills

- Proven expertise in both Microsoft Office Suite and related systems

- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

- Expert understanding of quality laboratory and technical procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

- Expert understanding of related aspects of quality laboratory processes and/or systems

- Expert knowledge of FDA Quality System Regulations, Good Laboratory Practices (GLP) and ISO/EN standards

-Knowledge of financial acumen as it relates to the business as well as quality laboratories

- Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

- Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality laboratories to the business

-Serve as core partner to senior leaders in Business Units, Functional Groups, and Regions

- Strict attention to detail

- Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

- Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

- Frequently interacts with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team

-Participate and present at meetings with internal and external representatives

- Resolve operational and scheduling issues

-Dedicated to quality client service and pro-active and responsive to client needs.

- Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

-Develop relationships and leverage them to influence change

- Support and solicit input from team members at all levels within the organization

- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Required Skills

Optional Skills

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Primary Work Location

DOM Santo Cristobal - Nave 25-Merengue

Additional Locations

Work Shift

DO Admin SH 45H 8AM-5PM (Dominican Republic)