Position Summary

The Manager, Quality Operations is accountable for driving results in a fast paced environment by continously challenging the performance of quality standards, systems and opertating procedures. The Manager, Quality Opertaions provides leadership to the site Quality team who perform 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 collaborates other site management to ensure department goals and objectives are met. This leader also supports the day to day Operations team from a Quality perspective. This support provides the recommended quality voice in daily decisions. The Manager, Quality Operations interacts with clients and regulatory agencies regarding quality issues, audits and inspections. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Ensures GMP compliance to regulatory requirements and Company procedures.
• 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 on 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.

Education and Experience

• Bachelor’s degree (Chemistry, Biology, Microbiology) required; master’s degree preferred.
• 5-8 years of related experience required, 10+ years preferred.
• 3+ years of pharmaceutical quality experience required; Prior CDMO or CMO experience preferred
• 5+ years of leadership experience required.
• Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• 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 working knowledge of Microsoft Office Software.

Supervisory Responsibilities

• Directly leads team of approximately 8-14 direct reports across 24 hour operations.
• Participates in the hiring process of other employees.
• Makes hiring decisions of other employees.
• Schedules and reviews the work of other employees.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements.
• Coaches, mentors and develops other employees.
• Prepares and delivers performance evaluations of other employees.
• Makes recommendation of disciplinary actions of other employees.

Decision Making and Supervision Required

• Uses professional concepts and critical thinking to solve complex problems.
• Independently determines methods and procedures, including assignments and the work of others.

Travel Requirements

• Up to 10% domestic travel

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 required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, knell, 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.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.