Director of Quality Assurance

Job Description

Job Description

Corporate Overview

Aluris Sciences is a contract manufacturing organization (CMO) headquartered in Carlsbad, CA with over 50,000 square feet of manufacturing space. The company is dedicated to serving highly innovative companies in the life sciences, diagnostics, drug-device, and combination product industries. Aluris is a full-service, cost-effective partner, providing complete solutions across technical transfer, formulation, filling, lyophilization, assembly, and final kitting of reagents, consumables, and combination products. Aluris provides quality and regulatory expertise to assure the highest in quality manufacturing and supply chain excellence.

Position Overview

The Director of Quality Assurance (QA) is responsible for leading and managing the company’s quality assurance and regulatory compliance programs. This role ensures that all quality systems align with regulatory requirements and industry best practices, maintaining compliance with ISO-13485, ISO 14971, GMP/GLP, QSR, 21 CFR 820.30, and other relevant medical device (IVD) regulations.

The Director of QA will work closely with the Vice President of Quality and Regulatory to develop and implement strategic quality initiatives, oversee external audits and regulatory inspections, and drive continuous improvement across the organization. This role also involves coaching and mentoring staff, managing compliance metrics, and supporting client engagements by serving as the company’s quality systems representative.

Success in this position requires strong leadership, a deep understanding of quality regulations, excellent communication skills, and the ability to build and maintain a culture of compliance and operational excellence.

What You’ll Do

• Lead and assist in performing all tasks necessary to achieve the organization's mission and help execute growth
• Work with the Vice President of Quality and Regulatory to formulation and execute the
• strategic vision.
• Work with the Vice President of Quality and Regulatory to develop and actively manage the company's quality system consistent with the culture and intent of the company
• Oversee and coordinate the quality management systems implementation.
• Accountable for maintaining a state of compliance to f CFR 21 820, 210 and 211.
• Act as the "management representative" within the quality plan.
• Will formulate and lead the management team to maintain ISO 13485 compliance.
• Will assist the leadership in implementation of the technology and process capability roadmap with specific emphasis on validation (10/OQ) and documentation support.
• Will be involved in strategic planning, evaluation, and professional development initiatives.
• Will recruit, hire and manage a motivated and highly talented staff of quality and regulatory professionals
• Provide leadership and/or support as needed throughout the organization, specifically all activities associated with bill of materials structuring, part numbering, SKU attributes, set­ up, training and quality management systems.
• Represent the quality systems acumen and quality systems capabilities of the company.
• Support all clients engagements as the quality system voice of the company and our capabilities
• Will actively work with the VP of Manufacturing to solve challenges in the production environment related to workflow, internal audits, material dispositions (MRP) and process changes/deviations.

What You’ll Bring

• Successfully served in a similar capacity in a contract manufacturing company for a highly regulated market, preferably the life science/pharmaceutical environment.
• Proven credibility as a Quality leader in the life science manufacturing environment.
• Experience and familiarity in reagent formulation, filling and finishing activities with several years of directly related accountability for quality in this form of manufacturing.
• Proven track record of exceptional performance in these FDA regulated environments with audit experience from the FDA and clients
• FDA rapport and relationships are strongly desired
• A familiarity with Lean Manufacturing cultures in a volume production facility
• Experience and proven results in driving process/technology validation efforts.
• Experience and expertise in communication exchanges with clients during tours, meetings, and audits.
• Consistently exhibited through their actions, decisions, and interactions (internally and externally), the highest standards of ethics and integrity.
• The ability to create, direct and implement corporate objectives in an environment with a high sense of urgency
• A proven capability to generate shareholder value
• Negotiation skills to maximize value in client/regulatory body discussions
• Experience building compliance and standardization of processes (building a scalable organization).
• Experience participating in ERP implementations managing and driving documentation control, bills of materials, routings and workflows.
• A track record of recruiting exceptional talent within the economic constraints of a small company.
• A "hands-on" management style with the interpersonal skills required to build a successful team and the desire to motivate, inspire and develop management team members
• High intelligence with effective analytical and problem-solving skills.
• Excellent oral and written communication skills and listening skills.
• A proactive style using initiative and perseverance in order to bring about meaningful change.
• Demonstrated high energy.
• Team Player.

What to Expect:

This is a full-time, 100% on-site position based in Carlsbad, CA, with a Monday–Friday schedule and 8-hour workdays, excluding meal breaks. Overtime, weekend, and holiday work may be required as business needs arise.

The position offers a flexible start time between 6:00 a.m. and 9:30 a.m.; however, employees are expected to maintain a consistent schedule. Any exceptions to the established schedule must be approved in advance by the manager.

What We Offer/Compensation

At Aluris Sciences, LLC. we value our employees and are proud to offer a comprehensive benefits package designed to support your well-being and financial future. Eligible employees enjoy:

Health & Wellness

• Medical, dental and vision coverage
• Health Savings Account (HSA) and Flexible Spending Account (FSA) options
• Company-paid life insurance
• Short-term and long-term disability coverage

Financial & Time Off

• 401(k) plan with company match
• Paid vacation
• California Paid Sick Leave
• Paid company holidays

Additional Benefits

• Employee Assistance Program
• Voluntary and supplemental benefit options

The pay range for this position is $195,000 - $205,000 annually. The final compensation offered will be based on a variety of job-related factors, including geographic location, skills, education, experience, certifications, and other relevant qualifications.

Aluris Sciences, LLC. is proud to be an equal opportunity employer committed to providing employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age or disability, or any other class protected by Federal, State or local laws. Argonaut complies will all employment eligibility verification requirements of the Immigration and Nationality Act and all must have the authorization to work in the US.