Be an early applicantLess than 25 applicants
Formulated Solutions · 3 days ago
Research and Development Quality Manager
Largo, FL
Full-time
Onsite
Senior Level
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Hiring Manager
Sandra Floyd
Insider Connection @Formulated Solutions
Responsibilities
Manage and oversee R&D Quality Assurance activities including New Product Development, Introduction & Launches, GCP Quality Assurance, and Technology Transfers.
Ensure research and development activities comply with regulatory requirements, guidelines, laws, and internal standards.
Define Quality and Risk Management standards, identify compliance risks, and manage them appropriately.
Establish activities supporting quality management for applicable processes.
Provide oversight for Analytical Method Development, Process Validation, investigations, Significant Quality Events, CAPAs, audits, etc.
Define metrics for R&D Quality, drive continuous improvement, and oversee stage-gate processes.
Participate in meetings, inspections, audits, and manage regulatory health authority inspections.
Review and approve Quality documents, escalate non-compliances, and implement Quality Strategy and guidelines.
Partner with Business Owners on data management practices and documentation for GXP data integrity.
Qualification
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Required
Bachelor of Science degree (Chemistry, Biology, Physics, Biomedical Sciences, Pharmacy, Industrial Pharmaceutics, etc., Master’s or PhD advantage Expert knowledge of NPD, NPI, NPL, GCPs particularly ICH requirements
Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
Proven ability in setting strategy for and driving quality process improvement initiatives
Strong leadership experience and mentoring skills
Strong global knowledge and understanding of international regulations applicable to the conduct of new product development, introduction and launches, clinical trials and pharmacovigilance operations
Strong leadership, coaching and mentoring experience, influencing, leading direct and/or indirect reports.
Demonstrated ability to manage multiple and diverse projects concurrently.
Demonstrated ability to develop positive relationships and collaborations.
Strong analytical skills; a strategic thinker, planner, and implementer.
Reliable, dependable, and consistent worker.
Strong ability to create practical and efficient processes.
Highly effective interpersonal skills in individual as well as in group settings.
Strong communication skills, both written and verbal.
Enthusiastic, genuine, ethical, fair, and loyal to the organization and its vision and goals.
Results-oriented; able to determine approaches to assignments.
Problem-solving skills with the ability to analyze situations and/or data while considering future impact and intangible variables.
Demonstrated attention to detail, accuracy, excellent review, and analytical skills in a fast-paced environment.
Must have strong oral and written communication skills and SOP-development experience.
Ability to work independently under general direction in a fast-paced environment.
Ability to travel up to 10% (domestic and international).
Company
Formulated Solutions
Formulated Solutions is a manufacturing organization for contract development.
Founded in 1999
501-1,000 employees
H1B Sponsorship
Formulated Solutions 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
Trends of Total Sponsorships
2023 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2014-03-28Private Equity· Undisclosed
Leadership Team
Eric Dann
Founder and CEO
Recent News
Fierce Pharma
2023-10-10
2022-12-21
Company data provided by crunchbase
