Associate Director, Quality Systems & Compliance

Date: Sep 23, 2022

Location: Miramar, FL, US, 33025

Company: Apotex

 

Aveva Drug Delivery Systems is a global leader offering a full range of research, development, and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage, and compliance rates for patients.

 

Job Summary

The Associate Director, Quality Systems is a senior member of the Quality Team and is responsible for continuously improving Quality at Aveva. 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.

Job Responsibilities

  1. Provide visible, results oriented leadership that supports Apotex’s Mission Statement and Apotex strategic plan.
  2. Lead actively the Quality Systems department by maintaining a sustainable Quality culture at the Aveva.
  3. Set internal quality procedures ensuring implementation and adherence to Global Quality Policies, Standards Operating Procedures and cGMP’s for Quality Assurance.
  4. Establish and maintain Quality performance metrics that support the corporate and site specific quality goals.
  5. Identify, coordinate and implement systems that assure cGMP compliance and continuous improvements.
  6. Be an active member of the Quality Management team and help support a team environment within all segments of Aveva Quality.
  7. Represent Apotex position and policy during regulatory inspections. 
  8. Participate as a member of the Aveva Incident Response Committee.

Customer Service Support

  1. Ensure proactive Customer Service is a prime focus in every area of the department.
  2. 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. 

Investigations Management

  1. Accountable for oversight of the investigation management system while ensuring all site investigations are handled in a compliant and efficient manner.
  2. 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

  1. Oversee management of the Product Review system with responsibility of timely creation and maintenance of all product reviews.
  2. 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.

 Change Control and Documentation Management

  1. Accountable for an overall surveillance of Change Control system related to commercial documents and data for Aveva manufacturing site.
  2. Ensure development and implementation of appropriate business processes and controls within Change Control system to ensure overall quality and compliance.
  3. Accountable for assessments, review and approval of all change control packages for changes to master production and packaging records.
  4. Liaise with other business units to meet training needs through maintenance and oversight of training records and plans.

Compliance and Risk Management

  1. Oversee development and maintenance of business metrics and reporting tools to monitor and review compliance activities such as CAPA management at the site. Using Risk Management tools, identify gaps and implement solutions.
  2. Oversee Escalation process.
  3. Responsible for incoming complaints processes.
  4. Ensure site compliance with DEA regulations for controlled substances.

 

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 management experience.
  • 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 experiences 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 through 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.

At Aveva Drug Delivery Systems, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Aveva Drug Delivery Systems offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami