Director, Pharma Storage

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.

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Job Summary

The Director, Pharma Storage is accountable for driving results in a fast-paced environment. The Director, Pharma Storage is a client-facing position responsible for regional oversight on behalf of the Pharma Storage department providing leadership and mentorship to all operations personnel within the region.

The Director, Pharma Storage ensures that Pharma Storage activities are executed in compliance with industry regulations, data integrity, and the quality management system. This leadership role manages short and long-term goals of the operation and implements and manages projects to ensure deadlines are met.

This role acts as a point of contact for the region with respect to Pharma Storage operations for all clients. The Director, Pharma Storage, participates in client quality audits and resolves outstanding audit issues. This role is responsible for improving staff competence, efficiency, and effectiveness.

The individual in this role is responsible for overseeing operations staff including managers, supervisors, leads, individual contributors and non-employees in Pharma Storage areas within the assigned regional scope.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Set department policy, goals, and metrics in alignment with company objectives.
• Monitor industry trends and market conditions to identify opportunities and potential challenges.
• Meet with key clients regularly to grow partnerships and to promote internal services.
• Resolve contractual or operational dilemmas with clients.
• Translate high level strategies into actionable plans.
• Attend and sponsor daily operational meetings, gather and escalate information to higher tier.
• Represents operations in audit meetings, tours, or business review meetings.
• Ensures integration of quality, safety, and GMP into daily operations at the floor level.
• Translates operational needs into presentations, metrics, or schematics for expansion opportunities.
• Manage, support, train, coach, mentor and evaluate Pharma Storage personnel.
• Responsible for writing, reviewing and/or approving Pharma Storage policies, documents, and records.
• Plan and establish work schedules, assignments, personnel and equipment to meet operational demand.
• Interface with business development teams to convey or understand customer requirements.
• Ensure completion of projects by reinforcement of professional accountability and sponsorship.
• Oversees facility-related commissioning activities, validation schedules, and release of equipment/facilities.
• Accountable for implementing CAPA within area of responsibility.
• Analyze business data to make data driven decisions to optimize the business and/or operation.
• Manage and support all operational practices in Pharma Storage.
• Assists other regions with startup activities, operational onboarding, training, or manpower, as needed.
• Other duties as assigned.

Qualifications

• Bachelor's degree required in business, technical or science related field of study.
• 12+ years of pharmaceutical or GMP industry experience that includes 6+ years of management experience.

Knowledge, Skills, and Abilities

• Strong knowledge of pharmaceutical regulatory requirements and cGMP required.
• Knowledge of quality systems and processes, change control, CAPA and data integrity required.
• Knowledge of storage requirements in a GMP facility.
• Has participated in /or lead regulatory audits.
• Demonstrated excellent administrative and leadership abilities.
• Proficiency with pharmaceutical industry regulations and best practices as they relate to storage.
• Excellent written and verbal communication skills; detail oriented.
• Exceptional organizational and reporting skills.
• Team building and problem-solving skills.
• Ability to plan, organize and manage work initiatives.
• Advanced knowledge of Microsoft Windows Office Suite and database management.
• Strong skills in leadership, coaching and influencing others, strategic planning, critical thinking and problem solving.
• Root-cause analysis, written communication, and presentation skills required.
• Strong business acumen.
• Promote a safe environment for work.
• High level of personal & professional integrity and trustworthiness with strong work ethic.
• Develop and manage a high-performing team, focused on quality, accountability, meeting and exceeding expectations.
• Write reports and business correspondence.
• Listen and respond well to external customers, partners, and colleagues at all levels.
• Goal and result oriented.
• Prioritize tasks according to business objectives and can pursue several objectives simultaneously.
• Works independently with a high degree of self-motivation.
• Collaborates effectively with others cross functionally to accomplish goals.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.
• Very effective listening skills with the ability to hear attentively and process information correctly.

Travel Expectations

• Up to 10% 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 may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.

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