Design Engineer

1 month ago

Long Eaton, United Kingdom Smart Surgical Appliances Limited Full time

Job Title: Project manager (Vendor Outsourcing, QC Specialist)

Job Location: Foster City, CA Hybrid: 3 days a week minimum

Job duration: 12 months with possible 6 months extension


Manager is looking for a Vendor Outsourcing, QC Specialist who will report to the Senior Manager of Vendor Outsourcing (VO).

The candidate will be responsible for conducting functional internal audits on behalf of Vendor Outsourcing to ensure inspection readiness.

This position will also be responsible for assisting in business process improvement initiatives to maximize quality and efficiencies.


The candidate should have a deep understanding of vendor outsourcing’s responsibilities throughout the vendor sourcing, contracting, and management processes as they will be reviewing VO’s functional responsibilities in support of the clinical development portfolio.

Thus, the candidate should also have an understanding of various clinical trial activities such as Clinical Trial Management Services, clinical monitoring, data management, Real World Data/Evidence (RWD/RWE), biostatistics, medical writing, Ph 1 CRU, central lab, biomarker lab, bioanalytical lab, RTSM, eCOA, medical imaging, safety, e-informed consent, mobile HCP services, telemedicine and wearables/sensors.


Daily activities will include, but are not limited to, working within a team environment and leading functional internal audits of VO’s electronical Trial Master File (eTMF) and Contract Repositories to ensure meticulous oversight of VO’s documentations, adherence to work procedures, compliance standards, and the preservation of data integrity.

The role also involves coaching VO team members to resolve issues from a QC standpoint and serving as a primary reviewer of QC data for inspection readiness.


The VO QC Specialist is expected to complete tasks and projects under minimal supervision and has the ability to manage competing priorities effectively and proficiently.


Demonstrates a thorough knowledge of Good Clinical Practice “GCP”, Good Pharmacovigilance Practices “GVP”, Good Laboratory Practice “GLP”, Good Documentation Practice “GDP” and ICH E6 R2 compliance requirements.


Demonstrates a thorough understanding of current global and regional trends in compliance.

Candidate has 5+ years of relevant experience in the pharmaceutical or biopharmaceutical industry; and, has a BS or BA.(1) PMP certification or equivalent certification, (2) Candidates can be current or former project managers & (3) Project management experience in Pharmaceutical or Healthcare industries


Skills:

• Strong interpersonal communication skills

• Attention to detail and proactive management of quality findings will be integral to the team’s success

• Strong project management, organization, and critical thinking skills

• Comfortable interacting with internal stakeholders and external vendors

• Executive presence


Intake Notes:


Required Years of Experience: 5 years

Required Degree or Certification : BS or BA


Top 3 Required Skill Sets:

(1) Vendor Outsourcing

(2) Candidates can be current or former project managers

(3) Deep understanding of Quality and Compliance across Pharmaceutical or Healthcare industries


Top 3 Nice to Have Skill Sets:

(1) Quality and Compliance

(2) Vendor Contracting

(3) R&D Clinical


MUST: Great attention to detail, Growth Mindset, Proactive Leader to drive initiatives, Strong written and Verbal Communication skills, Passionate, and Able to thrive in a dynamic work environment.

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