Principal Investigator

About the role

We are seeking a talented and motivated Principal Investigator to join our team. In this role, you will be responsible for leading, coaching, and mentoring direct reports to accomplish organizational and department priorities.

Responsibilities

• 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.
• 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.
• Safeguards the integrity of the investigation process and 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.

Qualifications

• Experience 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.
• Knowledge and experience with cGMP, US FDA (audits and basic filing requirements), and EU (audits and basic filing regulatory requirements).
• 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.
• 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 organizing skills.

Compensation

Base Salary: $59,900 to $120,450 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer

• Annual performance bonus, commission, and share potential.
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute.
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries.
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits.
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

Recruiter Information

Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

EEO Statement

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.