Senior Manager, Validations

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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The Senior Manager, Validations for our parenteral site drives results in a fast-paced environment by leading the GxP system validation activities for the site. The Senior Manager ensures relevant equipment, facility, utility, and computer systems are in compliance with applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11 and Annex 11. This essential leader develops Standard Operating Procedures (SOPs), and templates related to Equipment, Facilities, and Utilities (EFU) systems and testing. Duties include overseeing and executing the validation of new systems, evaluating and performing periodic reviews of existing validated systems and maintaining required change control procedures. Responsibilities also include all aspects of the validation process, including developing and performing qualifications studies to document evidence to ensure that equipment and processes will satisfactorily meet the client and site specifications for quality. The Manager performs the qualification and validation of equipment, facilities, utilities, and systems and assists in equipment selection, specification, and the application of a risk-based approach when determining qualification strategies. The Manager of Validation leads a team of direct reports and provides quality and technical direction to cross-functional teams, actively driving and participating in strategies for continuous improvement.

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

• Ensures a robust quality system is in place for the site including equipment and laboratory instruments, utilities, maintenance, computerized systems and validation activities.
• Ensures validation protocols and processes comply with global regulatory requirements.
• Executes industry best practices that will successfully with stand regulatory inspections by regulatory authorities.
• Develops the site Validation Master Plan including anticipation of new requirements, maintaining validation status of current systems, and developing approaches and plans for new systems.
• Directs the qualification of EFU system related projects from internal staff and contractors.
• Leads investigations and completes CAPA assignments.
• Full understanding of Aseptic manufacturing and Isolator filling processes, Must, have steam and dry sterilization experience.
• Develops qualification project plans, deployment plans and test plans.
• Leads risk assessments to determine testing strategies related to projects and changes.
• Works with internal and external customers to identify and implement improvements within the Technology department related to change management business processes.
• Provides site stakeholder feedback to drive improvements to global initiatives, including the Pharmaceutical Quality System and Quality Risk Management program.
• Represents Validation in audits (internal and external), investigations and discrepancy resolution.
• Champions self-initiated or assigned projects within the context of company objectives and justify goals to management.
• Provides cross-functional participation to work closely with Manufacturing, Technical Services Engineering, Quality, and other interdepartmental staff to meet department and company goals.
• Participates in cross-functional teams to identify best practices, process improvement, efficiency and optimization,
• 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.
• Other duties as assigned.

• Bachelor's degree, preferably engineering or biotech/science discipline, and 10+ years of pharmaceutical or biotechnology industry experience required or a Master's degree and 7 years of pharmaceutical or biotechnology industry experience required.
• Advanced degrees or additional industry certification is a plus.
• 8+ years of supervisory/management experience.

• Prior sterile manufacturing experience required.
• Expert knowledge of GMP and quality systems.
• Excellent leadership skills and ability to coach, mentor, and influence others.
• Excellent verbal and written communication skills. Ability to read and comprehend detailed written instructions.
• Ability to develop, maintain, and deploy validation policies and practices in the following areas: facilities, equipment, process, cleaning, steaming / autoclave, computer systems, plant automation validation maintenance, validation document control and archival program, and analytical instruments.
• Ability to develop and assess the following Quality System elements for Validation: Quality Risk management program, CAPAs, change controls, Deviations, and GMP investigations.
• Ability to identify opportunities for continuous improvements, deploy best practices, and pro-actively update validation programs to reflect current regulations and trends.
• Ability to participate and lead partner audits and regulatory agency inspections for Validation.
• Ability to author and review responses to inspection observations and agency questions and sections of regulatory filings and annual product quality reviews.
• Ability to wear Personal Protective Equipment (including gowning) and understands and follows safety procedures and works in a manner to avoid injury to self and co-workers. Willingness to work with highly toxic and controlled materials.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.

• Up to 5% travel.

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 stand, walk, sit; talk or hear; use hands to finger, handle or feel. The employee is required some of the time to reach with hands and arms. The employee is required occasionally to climb or balance and taste or smell. The employee must frequently lift and/or move up to 10 pounds. There is no special vision requirement for this job. The employee may occasionally work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals.