Job Opportunity : Project Leader For US Pharm CQ And US Deliver Initiatives
Location : Horsham, PA, 19044, Hybrid Duration : 6 months contract, Full-Time
This position will lead and participate in projects for the integration of new products into systems that impact the US Pharm Local Operating Company (LOC) and Deliver organizations. Open to candidates located in Horsham PA or Titusville NJ.
Key Responsibilities Include, But Are Not Limited To :
- Provide project leadership and support related to quality systems for US Pharm CQ and US Deliver initiatives.
- Complete GMP documentation to ensure compliance.
- Track completion of project deliverables.
- Coordinate and collaborate with project team members.
- Propose process improvements.
- Provide routine project updates.
- Perform additional tasks as needed to support project deliverables.
Other Responsibilities :
Execute compliance activities on behalf of team leadership, including but not limited to the creation and revision of regional and local procedures and / or work instructions.Escalate appropriate issues to management.Make quality decisions based on assessments of compliance risks, balanced with overall business needs.Drive strategic initiatives for both CQ and distribution centers.Ensure strategies are implemented and closed out in a compliant and timely manner.Experience :
Minimum of 3 years' experience in the Medical Device, Pharmaceutical, or Consumer Products industry.Experience working in a highly regulated industry.Proven experience leading projects and influencing team members to achieve results without direct supervision.Strong written and verbal communication skills, with the ability to take initiative independently as well as collaborate as part of a team.Demonstrated problem-solving, decision-making, data analysis, inductive reasoning, critical thinking, and root cause analysis skills.Excellent communication and presentation skills.Strong change management, collaboration, and influencing skills to effectively partner across functions.Ability to work under tight timelines and maintain customer focus.Must be able to manage and provide leadership across multiple sites.Advanced proficiency in PowerPoint and Microsoft Excel, including VLOOKUPs and pivot tables.Demonstrated flexibility to handle complexity and multiple initiatives.Proven ability to successfully partner and collaborate with business partners outside of Quality.Experience interpreting compliance requirements and regulationsPreferred Skills And Experience :
Project Management certifications.Understanding of FDA 21 CFR Part 210, 211, ISO 9001 and / or ISO 13485.Understanding of Installation Qualification, Operational Qualification, Process Qualification (IQ, OQ, PQ), and associated report writing.Familiarity with Comet.Skills :
Project ManagementBiomedical IndustryPharmaceutical Regulatory ComplianceEducation :
Bachelor's / University degree.US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.