Principal Investigator

HIKMA•Bedford, OH

2d•$59,900 - $120,450•Onsite

About The Position

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. 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.

Requirements

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 organizing skills

Responsibilities

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.

Benefits

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
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave