Director, Global Validations
Company: Alcami Corporation
Posted on: February 8, 2019
Think Different. Do Different. Be Different.
Alcami is a world-class contract development and manufacturing organization (CDMO). We are a team of dynamic individuals committed to developing life-saving drugs around the world. A mindset of innovation, accountability and customer focus inspires us to be the most efficient, safe and reliable choice for our customers and the patients they serve. In return, we offer challenging careers, accelerated professional growth and the opportunity to be part of something different.
The Director, Global Validations is accountable for driving results in a fast-paced environment by leading and coordinating the activities of Validations personnel for Alcami. The Director develops production and resource plans to ensure budgets and project timelines are achieved. The Director interacts with vendors and peers in Manufacturing, Sales, and Finance, and Product Development personnel to optimize systems and procedures. The Director selects, develops, and evaluates personnel to ensure the efficient operation of the function. The ideal candidate will ensure that deliverables are met or expectations are proactively managed towards alternative solutions. The role will develop and implement key strategic polices and procedures. The ideal candidate will exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. This strategic position will develop, establish and maintain the overall validation program. 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.
* Oversees a wide range of activities assuring that processes, systems, facilities and equipment at contract manufacturing organizations comply with accepted GMPs and regulatory expectations utilizing a life-cycle approach, risk management tools (such as FMEA) and principles.
* Develops, establishes and manages global validation program via use of systems, policies, processes, procedures and controls to ensure the quality of processes and products conform to established cGMP standards and regulatory requirements. Harmonize site practices where it makes sense.
* Supports product development, process engineering, and continuous improvement initiatives.
* Develops and maintains/updates Validation SOPs to ensure consistent application of requirements and strategies.
* Develops and maintains a validation event (i.e. re-qualification) scheduling/triggering program within the CMMS environment or other compliant arena.
* Provides on-going technical support and engineering expertise to manufacturing operations, technology transfer and scale up activities.
* Works closely with cross-functional colleagues and teams to evaluate deviations/investigations, change controls as well as support inspections, audits, and regulatory submissions.
* Provides both strategic and tactical validation support to deliver consistent high quality documents, services, products and processes.
* Plans, coordinates and manges site validation activities of new facilities.
* Ensures appropriate escalation to the leadership team of significant departures of safety, product quality, supply or regulatory compliance.
* Forecasts and manages budget and resource needs.
* Optimizes efficiency of the working environment of the group.
* Ensures adherence to personnel and equipment SOPs and other regulatory requirements.
* Acts as the leader in formulating and implementing policies that meet current and upcoming compliance and operational trends.
* Provides significant input in budget process.
* Makes project/work assignments with communication of the expected timeline.
* Monitors the progress against the timelines.
* Provides troubleshooting support as needed.
* Monitors the quality of the group.
* Leads investigations.
* Effectively communicates with clients and internal groups.
* Prepares and carries out presentations related to the Company or project information.
* Evaluates personnel in a timely manner.
* 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 with 12+ years of pharmaceutical validations related experience, including 5+ years of management experience.
* Global role experience is a plus. Experience level applies to all degrees.
* 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.
* Demonstrated knowledge and hands on experience in the area of responsibility.
* Excellent understanding of the theoretical background/fundamentals of the work.
* Outstanding capability of client management.
* Ability to plan and forecast the financial performance of the organization.
* Understands industry business trends.
* Understands regulatory and technical trends.
* Basic understanding of hiring and employment practices.
* Strong knowledge in principles and practices of cGMP compliance and GMP manufacturing operations
* Demonstrated technical skills in the design, operation, and maintenance of process equipment and systems.
* Background in, technology transfer, scale-up and late phase clinical development; recent experience with PAI, commercialization a bonus.
* Must be highly organized, independent, with a sense of urgency to meet and exceed goals.
* Advanced problem solving capabilities.
* Consistent attention to details.
* Superior leadership skills.
* Excellent time management skills.
* Excellent organizational skills.
* Excellent communication and presentation skills.
* Computer proficient.
* Strong work ethic.
* Strong team player attitude.
* Able to work with employees effectively in other departments/groups.
* Aseptic experience a plus.
* Oral Solid Dose experience a plus.
* Directly leads team of approximately 4 - 8 direct reports.
* 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
Keywords: Alcami Corporation, Wilmington , Director, Global Validations, Executive , Wilmington, North Carolina
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