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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 Senior Manager, 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 Senior Manager, Quality Operations 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 Senior Manager 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 - 5:30pm.
Responsibilities:
- Ensures compliance with regulatory requirements and Company procedures. Specifically, 21 CFR 210 and 211 and Part 4.
- 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.
- Provides oversight to ensure thorough root-cause analysis for investigations.
- Supports implementation of 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.
- Provides Quality support to the Compliance team to maintain the on-time execution of scheduled internal audits and routine supplier management, 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 and a minimum of 10+ years of related experience required.
- A minimum of 7 years of supervisory experience is required.
- Prior GMP experience is required; prior CDMO experience preferred.
- Prior experience with GMP warehousing equipment validation, validation protocol review, 21 CFR Part 210 and 211. ISO17025 experience desired.
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.
Travel Expectations:
- Up to 10% domestic 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 is required to frequently talk or hear. The employee is frequently required to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, kneel, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.