Sr. Project Manager – Job Description

CREST Talent is hiring for a Sr. Project Manager to lead cross functional teams to complete large scale projects in the Life Sciences Industry and to be an integral part of an exciting, growing company.

CREST is a premier training, talent acquisition & coaching professional services organization focused on helping life science companies bridge the skill, diversity & resource gaps within the industry. We possess deep industry & professional service knowledge with first-hand experience helping organizations address constraints, impact lives and optimize value. As a core part of our mission, we remain a long-term partner for both talent and organizations. To that end, we remain engaged post training and placement to assist partners through Leadership Coaching, Growth & Marketing Strategy Development and Project Management leveraging our leadership team’s vast experience in Executive Level roles leading startups, SMB and Fortune 500 organizations.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Reporting to the Director, Life Sciences, the Sr. Project Manager will have responsibility for:

Objectives

Drive clarity around Project goals, milestones, assumptions, risks, timelines, budgets and other key program deliverables, while holding team members accountable for their deliverables. 

Ensure clarity through strong communication across the core project team, extended team and various internal/external stakeholders. 

Generate minutes for meetings as required, track and influence delivery of action items. 

Identify roadblocks and work with clients to eliminate them.

Support project team decision making and ensure clear documentation. 

Build and maintain strong relationships with internal and external partners. 

Communicate impact and changes to project scope, project schedule(s), and project costs. 

Develop conceptual plans and timelines for facilities projects to support fiscal planning and manufacturing requirements.

Develop planning documents for initiation of projects (Project Charter) and develop timelines and risk/impact assessments.

Must be advanced in Microsoft Project (create, manage, track, and reporting functionality), to deliver up to date project status.

Develop and update Quarterly reports that will be approved by the Client.

Coordinate all parties involved in Implementing upgrades to equipment. Coordinate with Vendors to provide a solution and a cost and coordinate with the client to implement upgrades.

Manage the development of solutions to new and existing equipment to make sure they are data integrity compliant.

Manage the development and upgrading of client validation documents including System Impact Assessments, Data Integrity Assessments, URSs, IOQs, PQs

Manage the development of Operational and Administrative SOPs

Develop Capital Equipment Requests and manage the project budgets.

Coordinate and communicate with the quality organization and manufacturing to ensure compliance while minimizing production disruptions.

Assist in the development, implementation, and maintenance of new and existing standards.

Ensure effective, timely written and oral communication with consultants and internal customers during all phases of the project.

Requirements

Knowledge of Project Management principles and software, including Microsoft Project.

Deep experience in contractor and vendor management.

Experienced working in a Life sciences organization or experience working in a regulated environment.

Experience participating in regulatory inspections (FDA, EU, ISO, etc) pertaining to commissioning, qualification, and validation activities.

Knowledge of FDA regulations, USP, GAMP

Experience with risk assessments, gap assessments, change controls and CAPAs

Hands-on experience with authoring, editing, and approving validation documentation.

Knowledge of budgeting, and scheduling practices.

Strong verbal and written communications.

Client focused mentality.

Experience managing Teams and having direct reports in the Life Sciences Industry

Ability to travel at least 50%. The remaining work can be done remotely.

Education and Experience:  

Minimum 10 years of project management experience 

Degree in an Engineering or Technical discipline 

5-10 years’ experience managing projects in the Life Sciences Industry

Experience as a consultant preferred. 

Team oriented individual. 

Knowledge of FDA pre-approval inspections

Benefits

Competitive Salary

4 weeks+ Paid Time Off (Vacation, Sick & Public Holidays)

All applicants who are offered employment will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with company policy and state law.

The company does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Job Type: Full-time

Pay: $115,595.00 - $123,704.00 per year

Benefits:

• Flexible schedule
• Paid time off

Compensation package:

• Yearly pay

Experience level:

• 5 years

Schedule:

• Day shift
• Monday to Friday
• Weekend availability

Work Location: Remote

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