Director, Manufacturing 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 Director, Manufacturing 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 Director, Quality provides leadership to the site Quality team who performs 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 Director of Manufacturing 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 GMP compliance with regulatory requirements and Company procedures. Specifically, 21 CFR parts 4, 210 and 211.
• Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Collaborates with site Operations and Technical leadership to ensure timely closure of deviations, non-conformance investigations, corrective actions, and other Quality documents.
• Conducts thorough root-cause analysis for investigations.
• Implements corrective and preventive actions to eliminate repeat observations.
• Guides, instructs, and coaches members of management in quality and compliance issues.
• Provides direct support and leadership during site regulatory inspections to ensure minimal observations.
• Engages in client audits and client interactions.
• Assists in driving on-time site responses to regulatory and client audit reports and provides direct oversight on commitments and content.
• 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, Engineering) required.
• 10+ years of pharmaceutical quality experience required, 12+ years preferred related experience in other pharmaceutical disciplines will be considered; 6+ years of management experience required.
• Prior pharmaceutical experience in sterile manufacturing, including syringe manufacturing, is required; prior CDMO experience preferred.
• Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review, 21 CFR Part 4/ISO 13485 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 business acumen.
• Strong understanding of company SOPs, and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong knowledge of cGMP requirements.
• Strong experience with client audits.
• Excellent analytical and problem-solving skill, with the ability to think strategically.
• Strong attention to detail as well as time and resource management.
• Good presentation skills
• Strong personnel and professional integrity and trustworthiness with