Associate Director, Laboratory Quality Operations

Alcami Corporation•Morrisville, NC

4d•Onsite

About The Position

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.

Requirements

Bachelor’s degree (Chemistry, Biology, Microbiology) required
10-12 years of related experience required
10+ years of pharmaceutical quality experience required
7+ years of management experience required
Prior pharmaceutical experience required
Expert knowledge of pharmaceutical regulatory requirements and cGMP required
Knowledge of quality systems and processes, change control, CAPA and data integrity required
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

Nice To Haves

master’s degree preferred
12+ years preferred
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 of aseptic processing of commercial or clinical parenteral required for parenteral site(s)
Knowledge of auditing preferred

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.