The Role
Manage cross-functional operational and inspection readiness initiatives in a regulated life sciences environment. Coordinate action plans related to deviations, CAPAs, and process improvements; track milestones, risks, dependencies, corrective actions, and deliverables; facilitate stakeholder meetings and issue resolution; maintain dashboards and leadership reports; support gap assessments, documentation, evidence collection, and inspection preparation; and deliver project summaries and lessons learned.
Summary Generated by Built In
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.
Your Role
We are seeking an experienced Project Manager to support cross-functional operational readiness and inspection readiness initiatives within a regulated life sciences environment. This individual will be responsible for coordinating action plans, tracking milestones, managing risks and dependencies, facilitating issue resolution, and providing project governance for assigned initiatives.
The Project Manager will serve as a key coordinator across stakeholders to drive timely execution and closure of readiness-related activities while maintaining visibility into project status, risks, and deliverables.
- Coordinate and track readiness-related actions associated with deviations, CAPAs, and operational improvement initiatives.
- Facilitate action planning meetings and ensure alignment of stakeholders on priorities, timelines, and deliverables.
- Monitor project schedules, dependencies, milestones, and due dates to support timely completion of assigned activities.
- Identify, communicate, and escalate project risks, barriers, and unresolved issues that may impact readiness objectives.
- Facilitate cross-functional triage and resolution sessions for operational flow interrupters and business-critical challenges.
- Track corrective actions, ownership, and closure status while maintaining visibility through project reporting tools and dashboards.
- Support inspection readiness activities through action tracking, gap assessment coordination, documentation management, evidence collection, and stakeholder preparation activities.
- Maintain and communicate project status updates, key performance indicators, action trackers, and leadership reports.
- Support operational readiness initiatives by managing approved work plans, milestone schedules, risk registers, and dependency tracking.
- Collaborate with Quality, Manufacturing, Engineering, Supply Chain, Validation, and other functional teams to drive alignment and execution.
- Facilitate lessons learned sessions and document recommendations for process improvements and future readiness efforts.
- Prepare final project summaries outlining completed activities, residual risks, open actions, and recommended next steps.
Requirements
- Bachelor's or advanced degree in engineering or related life sciences discipline. PMP certification is a plus.
- Minimum 3-7 years of project management experience within the regulated Life Sciences industry
- Experience coordinating complex, cross-functional projects involving multiple stakeholders and competing priorities.
- Strong knowledge of project management principles, including scheduling, risk management, issue tracking, dependency management, and status reporting.
- Demonstrated ability to facilitate meetings, drive accountability, and manage action-item closure.
- Excellent verbal and written communication skills, with experience presenting project updates to leadership teams.
- Must be authorized to work in the US.
- No C2C at this time.
Benefits
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
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Skills Required
- Bachelor's or advanced degree in engineering or a related life sciences discipline
- PMP certification
- 3-7 years of project management experience within the regulated life sciences industry
- Experience coordinating complex, cross-functional projects involving multiple stakeholders and competing priorities
- Strong knowledge of project management principles, including scheduling, risk management, issue tracking, dependency management, and status reporting
- Ability to facilitate meetings, drive accountability, and manage action-item closure
- Excellent verbal and written communication skills, including presenting project updates to leadership teams
- Authorization to work in the United States
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The Company
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
