Director, Manufacturing Quality Operations

Position Summary
The Director, 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 Director, Quality 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 works with lab management to ensure department goals and objectives are met. The Director, Quality interacts with clients and regulatory agencies regarding quality issues, audits and inspections.
Essential Functions

• Collaborates with corporate quality functions to ensure site compliance with the company’s Quality Management Systems (QMS).
• Ensures controlled documentation is generated, revised, approved and maintained per corporate and regulatory agency procedures.
• Engages in client audits and client interactions.
• Supports regulatory inspections to ensure minimal observations.
• Implements corrective and preventive actions to eliminate repeat observations.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Writes responses to regulatory and client audit reports.
• Oversees QMS to ensure timely closure of deviations, investigations, corrective actions, etc.
• Guides, instructs, and coaches members of management in compliance issues.
• Develops short and long-range goals and objectives for the site quality function.
• Develops, implements and maintains internal auditing program.
• Conducts thorough root-cause analysis for investigations.
• Develops and implements systems to aid in efficiency and compliance improvements for the site.
• 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.
• Ensures GMP compliance to regulatory requirements and Company procedures.

Education And Experience

• Prior experience with controlled substance reporting and handling, final product release, major equipment validation, validation protocol review, process validation protocol review and APRs preferred.
• Prior pharmaceutical experience required; prior CDMO experience preferred.
• 8-12 years of related experience required, 12+ years preferred.
• 10+ years of pharmaceutical quality experience in Aseptic processing & Environmental Monitoring required; 5+ years of management experience required.
• Bachelor’s degree (Chemistry, Biology, Microbiology) required; master’s degree preferred.

Alcami Non-Negotiables

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

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.
• 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.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• 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.
• 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.

Functional Competencies

• 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.
• Knowledge of auditing preferred.
• 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).
• Expert knowledge of pharmaceutical regulatory requirements and cGMP required.

Supervisory Responsibilities

• Ensures accuracy and relevance of assigned training curriculum.
• Indirectly leads team of approximately 15-20.
• Drives timely completion of training for employees to meet regulatory requirements.
• Makes recommendation of disciplinary actions of other employees.
• Prepares and delivers performance evaluations of other employees.
• Schedules and reviews the work of other employees.
• Directly leads team of approximately 3-5 direct reports.
• Participates in the hiring process of other employees.
• Coaches, mentors and develops other employees.
• Makes hiring decisions of other employees.

Decision Making And Supervision Required

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

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.
What We Offer You:

• Competitive salary with career advancement opportunities
• Bonus plan
• Voluntary benefits including short & long-term disability, life, accident, critical illness insurances
• Medical, dental and vision coverage from day one
• 401(k) with company match
• Company paid vacation, holiday and sick-leave

Diversity and Inclusion:
Alcami values diversity and we are c ommitted to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, sexual orientation, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.