Director Of Quality Assurance

Location: Deerfield Beach, Florida, US

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the United States.

Job Overview

This position holds overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site as well as corporate compliance to all applicable regulations including cGMP pertaining to all the markets currently served by the operations functioning on the assigned site. It is the lead quality assurance function for the respective quality system/site. Actively provides guidance to multiple departments and site regarding compliance to all applicable SHL Corporate Quality and Regulatory procedures, including applicable Agency policies and regulations. Job holder is directly involved in the establishment of corporate procedures. Ensures that products and/or materials are tested/released strictly under cGMP conditions and disposition is taken on time as per the committed Production Plan of every month and/or procedural requirements. Follow up on total quality activity to ensure that the organization’s quality system comply with all relevant standards, regulations, licenses and certifications. Products and services are conforming to specifications; meet internal and external quality expectations.

Main Responsibilities

• Interact with senior management to address critical quality and compliance issues.
• Coordinate with Corporate Compliance regarding Global QA, Formulation Development, Analytical Development and the Chemical Division for key corporate issues (i.e., provide inputs for improving the quality of our products).
• Ensure that follow-up of Corrective and Preventive actions deemed necessary are being performed at each location.
• Coordinate with all other department management and resolve quality related issues.
• Ensure each facility is audited for all cGMP requirement as per the appropriate Regulatory Agencies (e.g. FDA, DEA, HC, EU, etc.) and prepare audit reports showing all cGMP non-compliance areas as per corporate audit policy. Share results with respective Managers/ Business Unit Heads for correction.
• Develop and implement quality systems like TrackWise, Documentum, LIMS etc. for monitoring effectiveness of CAPA, Change Controls, and Batch Record Release systems for commercial production.
• Annual performance assessment of entire Quality staff working at site.
• Direct and lead the audit function and take appropriate action to assure regulatory compliance.
• Drive performance and accountability of QA team using meaningful metrics and reports.
• Coordinate with Regulatory Department for timely filings of ANDA projects.
• Provide management and guidance to Quality Control department staff to ensure the department is in compliance with current Good Laboratory Practices (GLP) and company policies.
• Review/approve deviations, investigations, market complaints, protocols, SOPs and any other reports as needed.
• Facilitate regulatory requirement training to improve the awareness at the manufacturing site.
• Provide management and guidance to Quality Assurance department staff to ensure the department is in compliance with current Good Manufacturing Practices (cGMP) and company policies.
• Review and approve cGMP audit plans for the entire year- suggest sites and areas to audit for the year and drive arrangements to audit.
• Develop and implement the management of SOP and applicable regulations trainings like e.g. GMP training programs.
• Corporate Quality Representative for all Regulatory, corporate, customer and vendor audits.
• Involved in vendor development and qualification program (i.e., audit the vendors as per in-house SOP to ensure that all vendors are complying to cGMP standards).
• Assist with preparation for and host the FDA and other regulatory compliance audits.
• Coordinate with corporate QA for any regulatory and cGMP Audit needs as necessary.
• Alert head of Global QA and Regional Director of any critical cGMP and/or non-compliance at any of the above mentioned locations.
• Cost improvement planning of QA & QC department to increase productivity and efficiency of quality unit whilst maintaining compliance.

Skills and Qualification

• Able to communicate effectively and work within cross-functional teams.
• Proficiency in Microsoft Excel and Microsoft Word is a must.
• BS/MS in Science or related degree.
• At least 10 years of pharmaceutical and/or medical devices quality assurance experience.
• At least 5 years of management experience.
• Ability to function with minimal supervision.
• Knowledge of Good Manufacturing Practices & Good Documentation practices.

We Offer

• Various opportunities for personal and professional development within a global organization
• Competitive compensation package
• Challenging assignments in a fast-growing and innovative industry
• Modern working environment with state-of-the-art facilities and technologies
• Position in a dynamic, international team of highly skilled professionals

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents via the Easy Apply button or directly to [email protected].

For more information on SHL Medical, please visit: linkedin.com/company/shlmedical/life

Is this not quite what you are looking for? Further interesting career opportunities can be found on: shl-medical.com/careers

Please note: We do not consider applications from recruitment agencies for this position.