Audit Compliance Manager

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 Manager, Audit Compliance is accountable for driving results in a fast-paced environment, continuously challenging performance in regard to quality standards, systems, and operating procedures. Responsibilities include oversight of client audit response and associated team. This position will be performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements. Activities include reviewing documents and data, CAPAs, Change Control, supporting audits and inspections, consulting on quality and compliance issues, and performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.

The Manager, Audit Compliance will ensure the audit team members partner with audit hosts and serve as subject matter experts, supporting tours when appropriate, responding to real-time Q&A, and providing documentation for audit requests. This position ensures responses align across sites, ensures appropriate CAPAs are in place, and submit responses to clients on time. This position ensures there is review of client audit trends, recurring observations, response cycle time, and CAPA effectiveness to drive continuous improvement. This position may also support client audit hosting activities, internal audits, and regulatory inspections.

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.
• Performs quality review and approval and authoring of complex documents, all types of data, audit responses, CAPA, change controls, etc.
• Collaborates with site Operations and Technical leadership to ensure timely closure of items associated with audits including observation responses, corrective actions, and other Quality documents.
• Supports for client and regulatory agency audits and inspections to ensure minimal observations.
• Assists in driving on-time site responses to regulatory and client audit reports.
• 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 area of expertise.
• Effectively resolves quality issues and concerns in a timely manner.
• Creates strong and effective relationships with clients.
• Other duties as assigned.

Qualifications

• B.S./B.A./M.S. in a related field with 10+ years relevant experience or equivalent.
• Relevant Leadership and GMP experience required.
• Strong knowledge in any of the following areas needed to support audits is preferred: Sterile Manufacturing, Oral Solid Dose Manufacturing, Packaging, Warehouse and supply chain, Chemistry Laboratory (large and small molecule), or Microbiology.

Knowledge, Skills, and Abilities

• Strong technical skills for area managing.
• Expert knowledge of pharmaceutical regulatory requirements and cGMP required.
• Knowledge of quality systems and processes, change control, and CAPA required.
• Strong Knowledge of auditing preferred.
• Excellent skills in leadership, coaching and influencing others, critical thinking and problem solving, root-cause analysis and written communication and presentation skills required.
• Good business acumen.
• Strong understanding of company SOPs, and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong attention to detail, as well as time and resource management.
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Promote a safe environment for work.
• Comply with the general policy of the company.
• High level of personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with minimal direction.
• Ability to develop and manage a high-performance team focused on quality, accountability and meeting and exceeding expectations.
• Communicate well orally both for internal customers and team members as well as external customers.
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners and colleagues at all levels.
• Highly goal and result oriented.
• Prioritizes tasks according to business objectives and can pursue several objectives simultaneously.
• Can work independently with a high degree of self-motivation.
• Knows how to obtain support from different collaborations.
• 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.