111 Quality Compliance Manager Jobs in Miami, FL
Vivex Biologics is Hiring a Quality Compliance Manager Near Miami, FL
Duties And Responsibilities
- Lead Quality Compliance team by managing schedules, assigning, and prioritizing their workload, establishing due dates, and completing their performance reviews.
- Initiate, lead, and/or support improvement projects together with operational departments to address, prevent, and reduce deviations.
- Provide technical guidance and ensures adherence to non-conformance, CAPA, complaints, planned deviation, and error correction procedures.
- Serve as a functional leader while working cross-functionally to provide quality and regulatory guidance to all functional areas in the organization.
- Lead quality planning activities to evaluate existing and develop new measurement systems to assess and improve departmental output.
- Support change control activities by providing expert review and feedback ensuring compliance with applicable procedures and regulations.
- Supports remediation efforts and implements controls to sustain improvements.
- Support Regulatory Affairs in the completion of supplier qualifications and audits.
- Provide guidance on regulatory compliance, change control, quality control, and risk management practices.
- Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures.
- Mentor and guide Quality Compliance team that meets agreed objectives and delivers best practice results, promoting excellence, and fostering a culture of technical excellence and innovation.
- Provides technical and administrative support and guidance to direct and indirect reports.
- Reports out on project progress to senior Quality Leadership and cross functional steering committees, as appropriate.
- Bachelor’s degree required, preferably in engineering or a related technical/scientific discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred. Master’s degree preferred.
- At least 8-10 years of experience in related Engineering or Quality role. Supervisory experience preferred.
- Experience with validations preferred.
- Strong knowledge of FDA, AATB, and cGTP guidelines preferred.
- Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
- Experience with Non-Conformance, Planned Deviation, Complaint, and Corrective and Preventive Actions (CAPAs).
- Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
- Effective oral, written, communication, and presentation skills.
- Strong organizational and communication skills.
- Strong analytical and problem-solving skills.
- Project management skills preferred.
- Ability to be assertive and influence others and lead significant change.
- American Society for Quality (ASQ) certification preferred.
- Certified Tissue Bank Specialist (CTBS) certification preferred.
Physical RequirementsWhile performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.
Direct reportsQuality Compliance Coordinator; Quality Compliance Specialist
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Vivex Biologics, Inc. is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, transfers, leaves of absence, compensation, and training.Vivex Biologics, Inc. complies with the Americans with Disability Act (ADA) which prohibits discrimination against qualified individuals with disabilities who, with or without reasonable accommodation, can perform the essential functions of a job.
Job Summary
Full Time
$109k-143k (estimate)
06/10/2024
07/03/2024
vivex.com
CUMBERLAND, GA
100 - 200
2013
LISA COLLERAN
$10M - $50M
Related Companies
The job skills required for Quality Compliance Manager include Regulatory Compliance, Leadership, Risk Management, Problem Solving, Project Management, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Compliance Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Compliance Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Compliance Manager positions, which can be used as a reference in future career path planning. As a Quality Compliance Manager, it can be promoted into senior positions as a Compliance Manager, Senior that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Compliance Manager. You can explore the career advancement for a Quality Compliance Manager below and select your interested title to get hiring information.
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