Planet Pharma ยท 20 hours ago
Sr Quality Systems Spec
United States
Full-time
Remote
Mid, Senior Level
4+ years expPlanet Pharma is a company focusing on quality systems in the medical device industry. They are seeking a Senior Quality Systems Specialist to provide oversight for the development and maintenance of quality programs, ensuring compliance with regulatory standards and managing audit preparations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
Coordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
Qualification
Required
Proficient in Agile systems for change control, technical writing, developing MS PowerPoint presentations, and project management support for Quality Management System processes relative to production and process controls within regulated industry, medical device preferred
Quality Systems Management experience (e.g., process ownership, auditor, document owner) in the area of Production and Process Controls sub-processes in regulated industry, Medical Device preferred
Project leadership or management experience
QMS Document change management knowledge
Requires a Bachelors degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Preferred
Statistical analysis experience (e.g., acceptance sampling plans, test method validation, process validation, design of experiments)
6 sigma certification
problem solving, communication, organizational skills
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase