Associate Director, Quality Systems & Compliance
Pharmaceutical Manufacturing
Miami/Ft Lauderdale Area
Our client is a Pharmaceutical Manufacturer located in the Miami/Ft Lauderdale area. They have engaged ttg Talent Solutions for a nationwide search for their next Associate Director, Quality Systems & Compliance. The position is located in South Florida.
The Associate Director, Quality Systems is a senior member of the Quality Team and is responsible for continuously improving Quality. Reporting to the Sr. Director, Quality & Compliance, the AD, Quality Systems and Compliance oversees quality systems, compliance, and risk management, in accordance with GxP, regulatory standards and Company policies and procedures. The AD, Quality Systems and Compliance is accountable and provides strategic direction for Quality Systems and Compliance department and manages diligently the activities and resources to support the business needs in compliance with regulatory requirements. 8-9 Direct reports.
Job Requirements
- Bachelor’s degree in science
- Minimum 10 years of professional-related experience in Quality Assurance within a pharmaceutical manufacturing environment and a minimum of 6 years of management experience.
- Must have knowledge of 21CFR (part 211 8020)
- Experience in Pharmaceutical Manufacturing operations and controls, change management processes, regulatory affairs, validation, leadership, influencing, and negotiation.
- Exhibited business acumen in understanding cross-functional processes, requirements, and relevant information flows, and translating gaps into solutions.
- Demonstrated strategic, process-driven, analytical, and critical thinking.
- Proven experience in holding people accountable, developing cross-functional teams, and facilitating decision-making processes.
- Strong organizational, interpersonal and communication skills.
- Proven ability to lead, manage and motivate subordinates.
- Demonstrated interpersonal savvy and relationship management/networking skills.
- Strong ability to deal with ambiguity and manage difficult situations.
- Proven ability to manage multiple, complex projects at the same time.
- Excellent ability to delegate and can effect change through others without direct involvement.
- Strong understanding of GMP requirements and their application in a manufacturing environment.
- Knowledge of international GMP requirements.
- Exercise innovative tactics and encourage others to demonstrate.
- Provide visible and results-oriented leadership
- Lead actively the Quality Systems department by maintaining a sustainable Quality culture
- Set internal quality procedures ensuring implementation and adherence to Global Quality Policies,
- Establish and maintain Quality performance metrics that support the corporate and site-specific quality goals.
- Identify, coordinate, and implement systems that assure cGMP compliance and continuous
- Be an active member of the Quality Management team and help support a team environment within all segments of the company’s Quality.
- Represent the company’s position and policy during regulatory inspections.
- Participate as a member of the company’s Incident Response Committee.
Customer Service Support
- Ensure proactive Customer Service is a prime focus in every area of the department.
- Establish an environment that promotes communication at all levels and strives to make all information available when and where needed. Build a network of technical support resources throughout the company to meet the challenges of the Quality Systems department.
- Accountable for oversight of the investigation management system while ensuring all site investigations are handled in a compliant and efficient manner.
- Interface with Supply Chain Management to ensure product status and dispositions related to investigations are made visible and support business needs while maintaining compliance.
Annual Product Review
- Oversee management of the Product Review system with the responsibility of timely creation and maintenance of all product reviews.
- Liaise with other business units (Commercial Operations, Technical Operations, Regulatory Affairs, Process Validation, Quality Control Laboratories & Supply Chain) to ensure timely notifications and resolutions of discovered potential product and process improvements and/or shortcomings.
Compensation
Salary $120k-$160K subsidized health benefits, and extensive PTO
A possible sign-on bonus provide for relocation – for the right candidate
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