Quality Assurance Manager
General Job Description:
Manages and coordinates activities and operations of quality assurance function and QA staff.
Coordinates with other managers and associates to identify critical success factors, develop measurement systems, and implement continuous process improvement methodologies. Manages the QMS and compliance to ISO 13485 and FDA requirements for the Lumos, Carlsbad facility.
Reporting to management team on a regular basis to review compliance status, priorities and resourcing.
Maintains, enforces, and measures quality assurance processes including CAPA and non-conformance process to correct deficiencies and formulate improvements. Review and approve CAPA and noncompliance closures ensure issues are closed in a timely manner.
Coordinate, evaluate and assist in developing action plans and follow up of quality issues.
Maintains and manages QA department budget.
Hires, trains, supervises, motivates, and develops quality assurance staff; provides day-to-day guidance and manages schedules and workflow.
Assigns duties and monitors quality of work; assures QA staff conforms to organizational policies and procedures and government regulations.
Plan and conduct internal quality audits.
Facilitate client-initiated audits and host audits and follow up action.
Ensure compliance with internal procedures to ensure that established quality and process procedures are being followed by appropriate personnel at all times.
Perform assessments and on-site audits of the company’s critical suppliers/vendors.
Review and approve process and QC documentation to release products to clients.
Manage change control and manage change control system.
Act as quality approver for documents requiring approval from a quality representative.
Manage and provide internal compliance training. Coordinate training across departments. Maintain training database and ensure that employees training records are up to date. Ensure new employees are training on SOPs per specific job function.
Ensure that appropriate records are properly controlled. Manage the proper storage and filing of controlled documents.
Act as in-house counsel for quality compliance, providing guidance for staff questions and solutions to quality problems. Performs other related duties as assigned by management.
Directly supervises employees within the quality department.
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Bachelor’s degree (B.S.) or equivalent in related field.
Four to six years related experience in pharmaceutical, biotechnology or medical device or equivalent.
Sound knowledge in ISO standards and applicable US and International Regulatory requirements for manufacturing FDA regulated products.
Basic understanding of process development methodology in industry, specifically with biologics.
Proven leadership and business acumen skills
Rudimentary experience with quality audits and audit hosting.
Demonstrated proficiency in supervising and motivating subordinates
Commitment to excellence and high standards
Excellent written and oral communication skills
Basic competence in subordinates’ duties and tasks
Ability to work with all levels of management
Strong organizational, problem-solving, and analytical skills
Ability to manage priorities and workflow
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Acute attention to detail
Demonstrated ability to plan and organize projects
Proficient on Microsoft Office, electronic document management systems; preferably Autodesk Vault
Proven ability to handle multiple projects and meet deadlines
Good judgement with the ability to make timely and sound decisions
Creative, flexible, and innovative team player
Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical
Application Information & Contact (How to Apply)
A cover letter outlining your suitability for the position must be supplied, along with a detailed CV of your experience.
Candidates who do not supply this information, will not be considered.
Please note only short-listed candidates will be contacted for an interview.
Apply today by sending your resume to Sarah.Glubka@planetinnovation.com.au