Site Head of Quality
The successful candidate will manage and Direct the Quality Assurance Departments of: Quality Systems, Documentation Control, Quality Control, Quality Engineering, Regulatory Affairs, Complaint Handling and Laboratory Services to ensure that products manufactured, and established systems comply with, GMP, ISO and applicable regulatory requirements. Provide direction on the use of quality systems and tools with a focus on process improvements. Act as the Facility Management Representative.
The Site Quality Head will report into the VP for Quality and will be responsible for Managing Quality Engineering, Reg Affairs, NPI, Quality Systems and Lab groups. They will be the contact for all Audits and will sit on the SLT. This is a strategic leadership position.
- Perform the duties as Facility Management Representative in accordance with FDA and ISO requirements to ensure overall Quality System is implemented and effective.
- Ensure that processes needed for the quality system are established, implemented and maintained. Maintain the facility compliance to FDA QSRs, ISO 13485, applicable MDD and Canadian requirements together with other applicable International Standards and regulatory requirements.
- Report to management on the performance of the quality system and any need for improvement.
- Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization. Promote process improvements through the use of recognised quality tools, internal audit program, appropriate CAPA systems and feedback systems (complaints etc.).
- Implement systems and controls to prevent product recalls and manage and postmarket surveillance actions in accordance with regulations and corporate requirements. Maintain responsibility for the systems that control/ensure the sterility of product and the release of product to the marketplace.
- Responsible for registration of products in all identified market places to support strategic build plan requirements and for maintaining registrations current. Maintain a change control system with appropriate controls which comply with applicable regulations.
- Manage and maintain a suitability resourced QA Dept with appropriately qualified personnel (i.e. Labs, Documentation, RA, Quality Engineering, Quality Compliance, Complaints, QC, Calibration and Supplier mgt.) to support facility needs and comply with international regulations. Manage personnel over three shifts. Maintain high morale within and across departments; handle personnel problems fairly and honestly in a timely manner. Promote cooperation and teamwork with all departments by open, candid communication and timely coordination.
- Ensure continual Quality System compliance
- Ability to manage large group of people with varied qualifications and very diverse responsibilities.
- Communications skills and ability to work with a variety of Departments, facilities and Regulatory bodies both National and International.
- Bachelor's Degree in engineering or relevant Science discipline.
- 10 + Years Quality Experience
- Excellent Leadership Skills
- Strong Communication and interpersonal skills
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