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QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

+ Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

+ Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.

+ Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.

+ Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.

+ Maintain and track project budget(s).

+ Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.

+ Actively participate in directing the evolution and defining the role of the project.

+ Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.

+ Maintain the master project plan and schedule for assigned projects.

+ Recommend and develop operational or process improvements for the performance and successful functioning of the project team.

+ Identify or lead focus area projects within the overall function of project management or related projects.

+ Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.

+ Ensure project work complies with practices, policies and standard operating procedures.

+ In a GMP environment, design, conceive, progress and implement new or changes to existing customer facing (SKUs) change records (CFSCRs) within the Change Control Management quality system.

+ Supports manager in leading all aspects of project(s) within Supply Chain: planning, implementation, monitoring, follow-up, completion, and business partner meetings.

Qualifications:

+ Bachelor's degree in related area Life Sciences, Engineering, Material Management

+ 4 years of Project Management experience

+ Hands-on experience with change control processes and systems.

+ Focused on commercial product life cycle, manufacturing, product variations and/or new product introduction.

+ Demonstrated ability on project management skills in balancing multiple responsibilities, priorities, tasks, and projects simultaneously.

+ Experience on Quality roles

+ Quality contact for change controls and or deviations

+ Knowledge of SAP and Bill of material (BOM) management

+ Experience with Regulatory field

+ Strong organizational skills, diligent and accurate, analytical

+ Fluent and highly proficient in English and Spanish communication skills (verbal and written) as peers will communicate in English across multiple countries

+ Writing skills

+ Experience on managing quality systems and/or managing deviations (non-conformances).

+ Experience in scheduling and coordination around production schedules.

+ Smartsheet knowledge, TrackWise (or equivalent quality or change control management) preferred, MS Office

+ Availability for Administrative Shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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