Lead QA Investigator

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.

Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated [Job Title] to join our team. In this role, you will be responsible for Leading, coaching, and mentoring direct reports to accomplish organizational and department priorities. Overseeing, assigning, reviewing, and approving investigations from atypical events in-house, critical complaints, or inter-company complaints focusing on CAPA and disposition of the lot(s) affected within 30 days of notification.

Managing staff of investigators on assessment of criticality, determination of affected batches (starting materials, bulk and finished product, root cause analysis, processes, assignment of CAPA, and leading technical meetings. Escalates quality and compliance issues to quality leaders as appropriate.

• Regular and predictable onsite attendance and punctuality.
• Leads the Investigation groups (QAI and Product Complaints.
• Responsible for deviations to ensure each event is classified correctly, all impacted materials are evaluated. Investigations are documented thoroughly and consistently.
• Use appropriate problem-solving techniques and process analysis to ensure determination of root cause and CAPA assignment.
• Provides timely feedback back to ensure continued growth of the team. Documents performance gaps and initiates intervention strategies up to and including disciplinary action.
• Anticipates and resolves obstacles having the potential of negatively impacting supply chain performance and or compliance.
• Communicates goals and results to key stakeholders including but not limited to direct reports, management, and peers.
• Oversees the development, monitoring and maintenance of QA investigation standards, processes, and procedures. Ensures the Problem-Solving Training is sustainable.
• Reviews and approves investigations from atypical events in-house, major/critical complaints, or inter-company complaints focusing on CAPA and disposition of the Lot(s) affected within 30 days of notification and ensures quality meets acceptable standards.
• Ensures staff conducts investigations according to procedures and processes.
• Acts as a quality liaison with the supply chain through appropriate meetings (P2P, etc.), regulatory authorities during inspections and business partners (corporate or customer) for relevant investigations.
• Acts as a quality liaison with Quality Control and Analytical Development to review phase I laboratory investigations and initiate phase II laboratory investigations.

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Up to Five (5) years of pharmaceutical, Chemical, or Food industry experience in Manufacturing, Quality, or Compliance is required
• At least three (3) years of previous investigation
• Must have knowledge and experience with cGMP, US FDA (audits and basic filing requirements), and EU (audits and basic filing regulatory requirements)

• Ability to work well and make appropriate decisions under time pressure and regulatory scrutiny
• Respond and act appropriately under stressful situations; such as, ability to evaluate quality issues and make decisions on product batches and campaigns quickly to minimize quality and business impact
• Demonstrated knowledge of analytical testing
• Demonstrated accomplishments in effectively applying cGMP and quality system regulations within the pharmaceutical industry
• Demonstrated knowledge of Quality Assurance, Production, Laboratories, Regulatory Compliance and Regulatory Affairs functions within a pharmaceutical production environment
• Possess excellent communication skills with the ability to influence/persuade individuals to gain acceptance of an idea or plan
• Ability to utilize active listening skills to understand the concerns or reasoning in order to be responsive, gain trust, and build strategic relationships
• Demonstrated knowledge of business and management principles involved in resource allocation, leadership technique, production methods and cGMP requirements, and coordination of people and resources
• Must possess demonstrated planning and…