Quality Manager (Regulated Industry)

About the role

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines.

With offices in Caguas, PR, Boston, MA & San Francisco, CA, MTG serves life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities

• Ensures the creation, revision, and enforcement of all aspects of MENTOR and the assigned client facilities Quality Management System (QMS)
• Lead the events & root cause analysis processes
• Oversight of the training programs and lead the inspection readiness programs, and vendor management programs
• Lead the review and administration of quality service level agreement (SLA) and Quality Management Systems as it pertains to quality and compliance requirements
• Develop and implement a strategy to ensure the client requirements are met
• Travel to support MTG clients and operations as required
• Establish objectives, mentor direct and reports and manage resources to ensure successful execution of the Quality Management System
• Provide support for design, execution and maintenance of quality system processes at respective departments
• Help department to coordinate training to operating procedure changes or new system implementation
• Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness
• Lead the implementation and maintenance of quality systems, including data analysis to identify opportunities for quality system improvement
• Maintain independence and oversight for clients documentation review and approval
• Reviews and approves protocols and final reports; escalate deviations from performance standards to their management
• Monitors and manages clients CAPA’s non-conformances and customer complaints
• Managed writing and review operating procedures (OP’s) to ensure compliance, efficiency and clarity
• Writing and reviewing quality system work instructions
• Conduct and/or support audit finding investigations including but not limited to mitigation, corrective action(s) and preventive action(s) where applicable
• Collaborate with department managers to develop and implement sustainable remediation action plans
• Leads continuous improvement projects for multiple sites
• Actively participates in assigned quality facilities projects
• Implement quality compliance processes (i.e. work instructions) and other harmonization processes at multiple sites
• Act as a point of contact for customers, suppliers, and internal employees regarding all contracts and compliance requests
• Work with all necessary internal departments to ensure compliance requirements are achieved as related to industry and customer expectations based on customer driven goals
• Management of all regulatory aspects including external and internal audits, investigations, and corrective/preventive actions
• Ensure the adherence of our employees to the standard operating procedures (SOPs) established by the clients
• Manage an internal audit process to assure the adherence of the client SOPs

Requirements

• Bachelor's degree is required; Sciences or Engineering is preferred
• Minimum of five (5) years professional experience in compliance, quality systems and/or internal auditing within the regulated industry
• Previous experience leading teams or projects
• Strong technical writing skills (English and Spanish)
• Ability to effectively read, write and verbally communicate in English and Spanish
• Computer literacy with MS Office applications (Word, Excel, Power Point, Outlook) and Quality Management Systems (e.g. Trackwise)
• Above average organizing, analyzing and a minimum of math (practical application of fractions, percentages, ratios, proportions, basic algebra) to determine organizational, Customer and regulatory problems and formulate corrective action plans
• Ability to adapt to changing responsibilities
• Effective interpersonal skills as demonstrated through prior experience
• Ability to work independently under minimal guidelines and supervision
• Working knowledge of applicable regulations and standards, including, but not limited to, GMP, GDP regulations and ISO standards
• Ability to motivate, train and develop staff within the MENTOR’s team
• Willingness to demonstrate through daily activities a model of continuous monitoring of quality system activities to ensure compliance with documented standards
• Demonstrated ability to analyze data and performance metrics
• Decision making capabilities