The Director, Quality 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 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.
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).
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.
Education and Experience
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 pharmaceutical experience in sterile manufacturing is required; prior CDMO experience preferred.
Prior experience with final product release, major equipment validation, validation protocol review, process validation protocol review
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.
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.
Directly leads team of approximately 3-5 direct reports.
Indirectly leads team of approximately 15-20.
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.
Up to 20% domestic travel
What We Offer You:
Competitive salary with career advancement opportunities
Profit sharing bonus plan
Medical, dental and vision coverage from day one
401(k) with company match
Company paid vacation, holiday and sick-leave
Voluntary benefits including short & long term disability, life, accident, critical illness insurances