Job Description

The Associate Director of Internal Auditing position reports to the Audit Management and Reg Intel Lead in Development Quality.  The Associate Director is responsible for developing, implementing and maintaining robust processes and procedures used to ensure continuous compliance of investigational medicinal products with cGMPs and relevant international regulations (e.g., USA, EU).  The Associate Director will lead and support activities that include, but are not limited to internal audits, GMP readiness, Health Authority inspections, Quality Risk Management and general compliance initiatives.

The primary responsibilities of this role include, but are not limited to:

• Independently lead and support comprehensive internal audits and assessments of GMP facilities and business applications / systems supporting clinical supplies manufacture, testing, storage and distribution to ensure compliance to relevant regulations, policies, and procedures. 

• Issue reports summarizing findings and track resulting actions to satisfactory closure to maintain appropriate risk posture for the site. 

• Develop and maintain metrics and key performance indicators to measure trends and improve quality performance. Raise unresolved issues or trends to relevant management. Present outcomes to management and governing Quality Councils when applicable.

• Maintain an expert level of knowledge about GMP requirements and industry trends as described in applicable worldwide regulations. Provide guidance and interpretation of GMP, regulatory, and compliance standards.

• Develop and harmonize procedures and processes that promote, facilitate and ensure compliance with worldwide regulations and industry standards in support of the company’s objectives.

• Lead and support GMP readiness activities for new manufacturing facilities, laboratories and support areas.

• Support the preparation and execution of Health Authority Inspections and our Company Audits as needed.

• Promote a culture of quality and operational excellence.  Proactively identify, develop and implement opportunities for improvement and work across multiple organizations to influence and implement solutions.

• Represent Development Quality on inter-departmental and cross-functional teams, ensuring the flow of information and providing Quality guidance.

• Support the Risk Management program as needed by participating in the risk identification and remediation for risk assessments.

Education:

• Required: Bachelor's Degree in appropriate Science (chemistry, biology, biochemistry, microbiology), IT or Engineering discipline

• Preferred: Advanced degree

Required:   

• Minimum 8 years of experience in the pharmaceutical, biopharma/biologics or related industry.

• Experience in multiple functional areas such as quality assurance, computer system validation, quality control, manufacturing, research and development, supply chain, facilities and engineering.

• Extensive knowledge of FDA and EU GMP regulations as well as ICH guidelines.

• Demonstrated knowledge and direct experience with the application of System Document Lifecycle requirements in GMP areas.

• Experience leading audits.

• Ability to travel between sites (e.g., West Point, PA and Rahway, NJ).

• Strong leadership skills and the ability to lead cross-functional teams.

• Experience using electronic quality systems to monitor, report and track quality tasks and key performance indicators.

• Excellent attention to detail.

• Proficient with digital tools and computer applications; competency in MS PowerPoint, Excel, and Word.

• Excellent verbal and written communication and presentation skills.

• Ability to independently prioritize and manage multiple projects and tasks simultaneously, ensuring timely delivery and meeting business objectives.

Preferred:   

• Familiarity with R&D or clinical supply areas and processes.

• Experience with computer system applications (e.g., Delta-V and/or PAS-X, SAP, electronic laboratory notebooks, Veeva, LIMS, Empower).

• Experience using AI tools and applications.

• Demonstrated experienced using Quality Risk Management tools.

• Experience leading and/or supporting US and EU health authority inspections.

• Superior collaboration and teamwork skills.

• Understanding of lean sigma principles and tools.

• Sterile manufacturing experience and knowledge of US and EU aseptic processing guidelines.

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