Associate Director, Calibration Services

 

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 Associate Director, Calibration Services is responsible for the overall direction of the metrology department. Provides leadership and mentoring to lab personnel. Conducts the lab activities in compliance with the quality management system. Provides technical guidance. Actively supports and maintains ISO 9001 certification and ISO 17025 accreditation. Improves lab competence, efficiency, and effectiveness. Defines and directs the short and long-term goals of the department. Direct responsibility for departmental P&L. This position provides managerial guidance for the administrative support for Alcami Pharma Services. The Associate Director assists with lab issues as they arise, handles routine questions and problems, and interfaces with customers and other departments as necessary. The Associate Director provides training and mentoring to all staff that report into the role.

On-Site Expectations

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

Responsibilities

• Represents the department in meetings, collaborates, and cooperates to achieve cross-functional improvements and business goals.
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
• Manages the day-to-day operations for assigned area.
• Ensures all staff members are fully trained.
• Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
• Recruits, trains, develops, and retains staff for the effective process of departmental operations.
• Provides technical guidance for troubleshooting and investigating simple to complex issues in the area of expertise.
• Applies statistical analysis for interpretation of project data.
• Ensures all cGxP data generated for projects are managed and evaluated as described in relevant internal procedures and regulatory requirements.
• Effectively resolves quality issues and concerns in a timely manner.
• Actively contributes to the preparation and coordination of internal audits and regulatory inspections.
• Creates strong and effective relationships with clients.
• Maintains a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses.
• Prioritize goals to meet company objectives.
• Approve metrology methods for software, hardware, & instrumentation.
• Establish and schedule testing to support lab accreditation, evaluate test results and personnel.
• Determine and document appropriate methods for estimating uncertainty.
• Evaluate and resolve quality issues relating to metrology.
• Identify and resolve nonconformance in the metrology department.
• Report on metrology activities at Management Review Meetings.
• Provide training and mentoring to staff on general metrology principles and specific metrology procedures, sharing best practices, and industry knowledge.
• Write, revise, review, and approve metrology procedures.
• Evaluate staff and equipment utilization to determine future needs.
• Determine appropriate laboratory housekeeping standards and foster compliance.
• Support sales initiatives as necessary.
• Support staff at both customer and remote Alcami locations.
• Assume responsibility for annual budgeting and costs within the department and review the monthly department income statement with Finance and Senior Management.
• Create a culture which empowers the staff, focuses on the Alcami values, recognizes those who wish to grow/advance and provide them a path to do so.
• Other duties as assigned.

Qualifications

• Bachelor of Science in Metrology, Manufacturing Technology, Engineering or a related technical degree, or 10+ years calibration experience with a higher educational degree.
• At least 4 years of management experience.

Knowledge, Skills, and Abilities

• Strong technical skills for area managing.
• Basis business acumen.
• Strong understanding of company SOPs and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong knowledge of cGMP requirements.
• Experience with client audits.
• Strong understanding of basic lab techniques.
• Strong knowledge of FDA, EU, and ICH requirements and i