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 Director, Audit Compliance is accountable for driving results in a fast-paced environment by continuously challenging the performance of quality standards, systems and operating procedures. The Director of Compliance is responsible for providing leadership to the compliance group that is typically staffed by professional, salaried employees performing quality compliance functions across multiple company locations. The Director, Compliance interacts with site leadership, clients, and regulatory agencies as needed regarding quality issues, audits, and inspections.

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

• Promotes a safe working environment in compliance with local and national safety regulations.
• Ensures that departmental processes and standards are in line with regulatory guidelines.
• Guides, instructs, and coaches across all levels of the organization on compliance issues.
• Participates and contributes to Alcami’s Quality organization.
• Ensures that the internal audit and client audit programs are maintained and drives remediation of opportunities observed and aids in continual compliance improvements across all sites.
• May serve as lead inspector for internal and/or external audits where applicable.
• Support site regulatory inspections.
• Writes responses to regulatory and client audit reports, where applicable.
• Engages in client audits and client interactions.
• Maintains operational metrics to identify actions to improve performance.
• Ensures responsibility for the effective implementation of harmonized compliance procedures across all sites.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Understands and communicates cascade communication from Executive management.
• Directs the development of short- and long-range goals and objectives and assures that year-end goals are attained.
• Ensures the implementation of company strategy across sites for harmonization and process improvements initiatives.
• Demonstrates departmental financial accountability and will assist in the preparation and administration of budgets and monitor and analyze cost against budget.
• Ensures that departmental performance and personnel qualifications meet the expectations of customers (internal and external) and support the achievement of broader business goals.
• Provides encouragement and positive reinforcement to subordinates and requires subordinate management staff to do the same.
• Initiates employee hire, promotion, discharge, or transfer and will participate in the selection process for subordinate personnel.
• 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 providing regular feedback and performance management evaluations.
• Other duties as assigned.

• Requires a related Bachelor’s degree with 12+years of relevant experience within the Pharmaceutical Industry.
• Must have at least 6+ years of experience in management roles.

• Expert knowledge of pharmaceutical regulatory requirements and GMPs applicable to areas managed.
• Auditing experience to include performing and hosting audits within and external of the company.
• Awareness of industry trends related to areas managed.
• Consistent attention to details.
• Excellent skills in leadership and coaching others, strategic planning, critical thinking and problem solving, root cause analysis and written communication and presentation skills.
• Excellent performance management and employee development skills.
• Excellent time management, organizational, presentation and leadership skills.
• Computer proficient.
• Good understanding of hiring and employment practices.
• Strong understanding of financial and budget concepts.
• Ability to train and mentor others.
• Excellent written and verbal communication skills.
• Able to work effectively with employees at all levels.

• Up to 15% travel expected.

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.