Alcami Corporation · 10 hours ago
Associate Director, Laboratory Quality Operations
Morrisville, NC
Full-time
Onsite
Lead/Staff, Director/Executive
10+ years expAlcami Corporation delivers reliable solutions that unlock the potential of transformative medicines. The Associate Director, Laboratory Quality Operations is responsible for driving quality standards and leading the Quality team in compliance with regulations and operational procedures.
Pharmaceuticals
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
Qualification
Required
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
Knowledge of aseptic processing of commercial or clinical parenteral required for parenteral site(s)
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
Up to 10% travel required
Preferred
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 auditing preferred
Company
Alcami Corporation
Alcami is a US-based contract development and manufacturing organization headquartered in NC with 45+ years of experience advancing pharmaceuticals and biologics from development to delivery.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase