Associate Director, Laboratory Quality Operations

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Associate Director, Laboratory Quality Operations is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems, and operating procedures. The Associate Director, Laboratory Quality Operations provides leadership to the site Quality team who perform quality review and approval of documents, data, protocols, qualifications, change controls, deviations, investigations, complaints, corrective action activities (CAPAs), and quality audits and inspections. This leader develops short and long-range goals, metrics, and objectives; directs the implementation of quality plans and works with lab management to ensure department goals and objectives are met. The Associate Director, Laboratory Quality Operations interacts with clients and regulatory agencies regarding quality issues, audits, and inspections.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Ensures and is ultimately responsible for compliance of laboratory operations within established SOPs, FDA regulations as well as compendial requirements.
• Collaborates with corporate quality functions to ensure site compliance with the company's Quality Management Systems (QMS).
• Oversees QMS to ensure timely closure of deviations, investigations, corrective actions, etc.
• Conducts thorough root-cause analysis for investigations.
• Implements corrective and preventive actions to eliminate repeat observations.
• Guides, instructs, and coaches members of management in compliance issues.
• Leads regulatory inspections to ensure minimal observations.
• Engages in client audits and client interactions.
• Writes responses to regulatory and client audit reports.
• Develops and implements systems to aid in efficiency and compliance improvements for the site.
• Develops short and long-range goals and objectives for the site quality function.
• Develops, implements, and maintains internal auditing program.
• Ensures controlled documentation is generated, revised, approved, and maintained per corporate and regulatory agency procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Other duties as assigned.

Qualifications

• Bachelor's degree (Chemistry, Biology, Microbiology) required; master's degree preferred.
• 10-12 years of related experience required, 12+ years preferred.
• 10+ years of pharmaceutical quality experience required.
• 7+ years of management experience required.
• Prior pharmaceutical experience required; prior CDMO experience preferred.
• Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.

Knowledge, Skills, and Abilities

• Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
• Knowledge of quality systems and processes, change control, CAPA and data integrity required.
• Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s).
• Knowledge of auditing preferred.
• Excellent skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
• Strong computer skills.

Travel Expectations

• Up to 10% travel required.

Physical Demands and Work Environment

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 100 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level is moderate. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE including respiratory protection as required. Employee occasionally may be exposed to moving mechanical parts and vibration. Must have a valid drivers license and reliable transportation available to travel between local sites.

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