Director, Quality (Packaging Operations for Manufacturing)

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, Quality (Packaging Operations for Manufacturing) 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 (Packaging Operations for Manufacturing) 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, Quality (Packaging Operations for Manufacturing) 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 to 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) required.
• 10 years of pharmaceutical quality experience required. Related experience in other pharmaceutical disciplines will be considered; 5 years of management experience required.
• Prior experience in packaging sterile 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.
• CDMO operations experience highly preferred, including technical transfer, qualification, validation, trouble shooting, Regulatory and Customer inspections, process scales-up and commercial operations.
• Must have experience in Packaging manufacturing experience across multiple dosage forms and configurations.
  
  

Knowledge, Skills, And Abilities

• Strong business acumen.
• Strong knowledge of FDA, EU, and ICH requirements and implementation for GLP and GMP in the pharmaceutical industry.
• Prior pharmaceutical or CDMO experience in technical functions of development or manufacturing.
• Excellent written and verbal communication and presentation skills required.
• Excellent project management, organization skills and ability to effectively multi-task required.
• Excellent problem solving and critical thinking skills required.
• Ability to work independently in a fast-paced and dynamic environment.
• Ability to build and grow strong customer relationships and ability to influence others.
• Ability to develop and manage a high-performance team focused on quality, accountability, and exceeding expectations.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
  
  

Travel Expectations

• Up to 10% travel required.
  
  

Physical Demands and Work Environment

The physical demands 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 25 pounds and occasionally lift and/or move assisted up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.