Quality Assurance Director

Job Title: Quality Assurance Director/DIRECTORDepartment: QualitySupervisor: Vice President

Purpose: Healgen Scientific LLC is seeking a Manager/Director of Quality Assurance to support our Quality and Compliance team. This position is responsible for providing leadership for the Healgen Scientific Organization focused on ensuring the release of high-quality products from the manufacturing facilities, while maintaining compliance with the Healgen Scientific Quality Management System, and applicable policies, laws and guidance.

Scope of the Role: The scope of the role includes but is not limited to Raw Material / Component release, Quality & Validation Engineering, Final Product Release and Site Compliance & Inspection Readiness. The role is responsible for developing both short-term tactical goals and objectives in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance.

Responsibilities:

• Bachelor's degree in science, Engineering, QA, or other related business field required.
• Leadership of the site quality organization ensuring efficient and flawless execution against the quality system and associated processes to ensure product quality and compliance with Healgen Scientific global polices, laws and guidance.
• Builds overall organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.
• Directs activities to ensure that the site is in the continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure the resources are sufficient, and projects are appropriately prioritized in alignment with regulatory requirements and business goals.
• Accountable as the host for any external regulatory inspections at all manufacturing sites.
• Acts with delegated authority, as the management representative for all sites to ensure quality management processes are implemented, awareness of regulatory requirements is promoted, and the effectiveness of the quality management system is reviewed by Healgen Scientific management.
• Responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, as applicable.
• Oversees day to day operations activities as required to support operations including raw materials & component release, maintenance of master validation plans, quality engineering with oversight for the root cause investigation, product disposition, corrective & preventive action, microbiology and environmental monitoring (as applicable) and final product release.
• Collaborates with operations and supply chain leaders to identify potential areas of process and product variability, addresses root causes and implements improvements through the CAPA process to ensure the flow of quality products through the supply chain.
• Utilizes data to assess the overall health and effectiveness of the quality processes/ system and identification of areas for process improvement. Leads strategy development at the site level and supports at the global level execution of a pipeline of continuous improvement initiatives to drive simplification, reliability, and overall effectiveness of the quality process.
• Responsible for annual quality plan (development and overall budgetary oversight for the site quality operations organization. Partners with finance and operations business partners to ensure that expense, headcount and capital are in alignment with business goals, financial targets and strategic plans.
• Holds responsibility for the quality issue escalation process.
• Actively participates in global quality & compliance leadership forums and provides leadership, coaching and mentoring to the broader Healgen Scientific organization.
• Partners closely with operations organization in the development of business strategies, goals and initiatives.
• Effectively negotiates and influences senior management, regulatory agencies and peers in the industry to ensure compliance with regulatory and business needs.

Qualifications:

• Bachelor's degree in science, Engineering, QA, or other related business field required.
• Post graduate degree (MA, MS, MBA of PhD) is preferred.
• A minimum of 8-10 years' experience in the Medical Device Industry with a strong preference for leadership experience in a functional Quality role for In Vitro Diagnostics.
• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment,
• Working knowledge of both FDA CDRH and CBER (licensed biologics) Quality Systems Regulations (where applicable), CMDR and ISO13485 standards.
• Ability to host / manage external Quality System inspections is required with a preference for experience gained with hosting CDRH (FDA) and other health authority inspections.
• Must be able to collaborate with and influence external regulatory agency personnel, and other external business partners including Raw Material / Component suppliers.
• Demonstrated knowledge of business impact of compliance issues and risk management is required. Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is a prerequisite. Expert knowledge of Good Manufacturing Practices, all applicable.
• Regulations and validation methods is necessary.
• Estimated travel 5% domestic.

Preferred:

• Black Belt in Lean or Six Sigma
• Proficiency in Excel / Minitab and able to analyze and interpret data.

The Key Working Relationships:

Internal Partners:

• Strong working relationships with Operations, Supply Chain, R&D, Regulatory Affairs and the broader organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Close collaboration with the other functions of the Company.

External Partners

• Vendors, Customers, Regulatory Agencies

The Work Environment:

No strenuous physical activity, though occasional light lifting of files and related materials is required. 80% of time in meetings, working with team, or talking on the phone, 20% of the time at the desk on computer, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position may require the use of Personal Protective Equipment as posted.

Equal Opportunity:

Healgen Scientific believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.

Please note: This position is onsite