Director, Manufacturing Quality Operations

Alcami Corporation

  • Morrisville, NC
  • Permanent
  • Full-time
  • 8 days ago
: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.Are you interested in joining our team? 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 strong work ethics and the ability to work independently with some direction.
  • Promote a safe environment for work.
  • Comply with the general policy of the company.
  • High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
  • Ability to develop and manage a high-performance team focused on quality, accountability, and meeting and exceeding expectations.
  • Communicate well orally both for internal customers and team members as well as external customers.
  • Ability to write reports and business correspondences.
  • Ability to listen and respond well to external customers, partners, and colleagues at all levels.
  • Highly goal and result oriented.
  • Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
  • Can work independently with a high degree of self-motivation.
  • Knows how to obtain support from different collaborations.
  • Tackles problems with enthusiasm and curiosity.
  • Treats colleagues at all levels with respect.
  • Very effective listening skills with the ability to hear attentively and process information correctly.
Travel Expectations:
  • Up to 10% travel expected.
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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

Alcami Corporation