Manager, Quality Systems

AVEVA DRUG DELIVERY SYSTEMS INC•Miramar, FL

23h•$110,000 - $115,000

About The Position

The Manager, Quality Systems is a member of the Quality Team and is responsible for continuously improving Quality at Aveva. Reporting to the Sr. Manager, Quality & Compliance, the Manager, Quality Systems oversees change controls, training, documentation control and provides QA oversight to validation activities, in accordance with GxP, regulatory standards and company policies and procedures. The Manager, Quality Systems is accountable and provides leadership to Quality Systems teams and manages diligently the activities and resources to support the business needs in compliance with regulatory requirements.

Requirements

Bachelor’s degree in science
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.
Minimum 5 years of professional related experience in Quality Assurance within a pharmaceutical manufacturing environment and a minimum of 2 years leadership experience.
Experience in Pharmaceutical Manufacturing operations and controls, change management processes, regulatory affairs, validation, leadership, influencing, and negotiation.

Responsibilities

Provide visible, results oriented leadership that supports Aveva’s Mission Statement and Aveva strategic plan.
Lead actively the Change Control, Training, Documentation Control and QA Validation areas by maintaining a sustainable Quality culture at the Aveva.
Set internal quality procedures ensuring implementation and adherence to Quality Policies, Standards Operating Procedures and cGMP’s for Quality Assurance.
Establish and maintain Quality performance metrics that support corporate and site specific quality goals in the Quality Systems area.
Identify, coordinate and implement systems that assure cGMP compliance and continuous improvements.
Be an active member of the Quality Management team and help support a team environment within all segments of Aveva Quality.
Represent Aveva’s position and policy during regulatory inspections.
Participate as a member of the Aveva Incident Response Committee.
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 Change Control and Training system while ensuring all processes in this area are compliant with regulations and are conducted in an efficient manner.
Accountable for an overall surveillance of Change Control system related to all change controls including but not limited to commercial documents and data for Aveva manufacturing site.
Liaise with other business units to meet training needs through maintenance and oversight of training records and plans.
Ensure development and implementation of appropriate business processes and controls within Documentation Management system to ensure overall quality and compliance.
Accountable for establishing and maintaining compliant and efficient processes for the review and approval, issuance and control of all master production and packaging records, all other controlled documents as well as appropriate management of all other types of documentation (reports, protocols, etc...).
Accountable for oversight of validation activities at the site (including equipment qualification, process and cleaning validation) while ensuring all validation processes in this area are compliant with internal procedures and current regulations.
Liaise with other business units such as Engineering and Technical Services to meet validation needs and requirements to ensure compliance.
As leader of Quality Systems department provide an environment that enables and encourages all employees to contribute to their full potential.
Recruits, trains, develops and manages effectively the ongoing performance of their direct reports, which includes, but is not limited to: Ensuring all Job Descriptions for direct reports are periodically reviewed, signed and stored according to our job description processes; Reviewing and updating development plans for all direct reports, ensuring that all direct reports are properly trained and qualified according to our Training and Employee Qualification Enterprise Policy; Effectively managing performance for direct reports according to the Performance Management Program, Attracting and retaining talent based on our talent management framework; Scheduling regular one-on-one meetings, probationary performance reviews and mid-year performance discussions; Providing regular coaching, feedback and recognition based on the expected behaviors, job description and performance on objectives; and Responsible to ensure compliance of team members (direct reports) with the Business Ethics and Compliance Program, Quality procedures, Safety and Environment policies, and HR policies.
Works as a member of a team to achieve all outcomes
Leads with a mindset that respects all cultural dimensions
Performs all work in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
Delivers all work in support of our Values of Collaboration, Courage, Perseverance, and Passion
All other duties as assigned