Quality Assurance Manager I
About The Position
The Quality Assurance Manager I manages and coordinates quality assurance activities of varying risk and complexity across one or more sites and customers. The role communicates quality policies and procedures, serves as an expert on selected governmental regulations, liaises proactively with customers on quality assurance, and develops and oversees site quality resources. The manager also supports global and cross-sector Quality and Regulatory initiatives and validated processes for regulated hardware, equipment, and software systems as applicable. The role oversees the maintenance and continuous improvement of the quality system, including management review, CAPA, internal audits, self-assessments, change control, document control, and standard operating procedures and work instructions. It oversees licensing, permits, and registrations; monitors regulatory compliance for products and services; and reports results to executive management. Additional duties include validating systems and equipment as applicable, developing associates, coordinating continuous improvement, reviewing audits and quality metrics, managing suppliers, producing management reports, serving as a primary customer contact for QA issues, and supporting business development and customer events.
Requirements
- Bachelor's degree or equivalent four years of work experience.
- At least 3 years of experience in a regulated environment or an ISO 9001-compliant or certified environment.
- At least 1 year of supervisory or management experience.
- Experience in manufacturing, food, life sciences, or the 3PL industry.
- Participation in successful standards organization registration in a complex environment.
- Experience supervising or implementing quality control programs.
- Knowledge of regulations such as FDA, GxPs, ATF, and DEA.
- Experience administering training for compliance with regulated standards.
- People development and people management skills.
- Process development skills.
- Sufficient computer application experience.
- Strong written and verbal communication skills.
- Data analysis experience.
- Training and facilitation skills.
- Self-management, problem-solving, and project management skills.
- Presentation, report creation, and solution execution skills.
Nice To Haves
- Certification related to quality control.
Responsibilities
- Manage and coordinate quality assurance activities across sites and customers, and communicate applicable policies and procedures.
- Serve as an expert on selected governmental regulations and liaise proactively with customers on quality assurance.
- Develop, manage, and oversee site quality resources; hire, train, and develop quality associates.
- Support global and cross-sector Quality and Regulatory initiatives and validated processes for regulated systems as applicable.
- Oversee maintenance and continuous improvement of the quality system, including management review, CAPA, internal audits, quality self-assessments, change control, document control, and SOPs/work instructions.
- Oversee the licenses, permits, and registrations process.
- Manage oversight of regulatory compliance for products handled and services performed, assessing performance against applicable cGxP, contract, and customer requirements and reporting results to executive management.
- Ensure systems and equipment are validated when applicable and that change control processes are maintained.
- Monitor associate training and development to ensure compliance with processes and regulations.
- Coordinate with the continuous improvement team to focus and direct continuous improvement activities and workshops.
- Review and provide recommendations on regulatory, customer, and third-party audits.
- Review quality assurance metrics and identify organizational trends.
- Serve as the primary customer contact for QA-related issues and initiatives as needed.
- Develop, distribute, and maintain regular management reports.
- Manage site suppliers and prepare for, receive, and act on audits.
- Provide business development support and represent DHL at customer events and meetings as required.
Benefits
- Medical, dental, vision, and prescription benefits.
- Discounted stock purchase.
- General Bonus Plan.
- Generous PTO policy.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
