Sr. Specialist, Regulatory Intelligence & Compliance Training

Job Title:      Sr. Specialist, Regulatory Intelligence & Compliance Training

Location:      Columbus, OH

Job Type:     Full time

Req ID:         10787

 

 

About Us:

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.

 

Description:

We continue to be committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Sr. Specialist, Regulatory Intelligence & Compliance Training.

 

In this role, you will be responsible for determining requirements, sets standards, and ensures core GMP, GxP, and DEA compliance training programs exist within the organization.  Ensures the compliance programs meet applicable regulatory authority requirements such as FDA, DEA, EMA, etc.  Diagnoses and develops solutions to close compliance knowledge gaps within the organization.  Collaborates with department management on core compliance training requirements and programs to ensure alignment.  Facilitates and delivers compliance training and workshops.  Responsible for domestic and international regulatory intelligence and interpretation of the regulations (organizational regulatory intelligence - ORI). 

 

Key Responsibilities:

• Ensures core GMP, GxP, and DEA compliance training programs exists and meet regulatory requirements with applicable regulatory authorities such as FDA, DEA, EMA, etc.
• Determines standards and expectations for site core compliance training requirements and programs. Communicates requirements to the applicable departments.
• Oversees internal and external commitments made associated with training.  Ensures commitments are met and training is effective.
• Manages and owns core compliance training programs (e.g. Inspection Readiness, GMP and DEA annual training, supplier auditor training, compliance on-boarding requirements, etc).
• Identify content to develop and deliver compliance training courses and workshops using different facilitation methodologies (e.g. classroom, eLearning, virtual, etc).
• Evaluates and seeks feedback on facilitation skills to ensure expectations are met and continuous personal development.

 

• Maintains connectivity with key stakeholders to ensure alignment within the organization with compliance training program decisions:
• Leverages organizational regulatory intelligence (ORI) to determine and interpret compliance training needs.
• Collaborates with the Site Training and Technical Training Centers of Excellence (COE) regarding compliance training programs & requirements, training schedules, and facilitator assignment.
• Represents Regulatory Compliance on the Training COEs, Quality System Compliance and Performance Board and other teams as applicable.
• Collaborates with L&D, Operations, Laboratory, and Warehouse to ensure training alignment.

 

• Identifies, diagnoses, and reduces the risk associated with compliance gaps for GMP, GxP, and DEA within the site by conducting regulatory intelligence searches and interpretations.
• Interprets and communicates domestic and international regulatory requirements (e.g. 21 CFR Parts 4, 11, 210, 211, 820/QSMR, 1300, DEA, DSCSA, EMA, EAEU, WHO, etc).
• Conducts and facilitates gap assessments of guidances or regulations.  Partners with impacted areas to determine solutions to close gaps.
• Identifies, evaluates, and diagnoses compliance knowledge gaps associated with GMP, GxP, & DEA using ORI (e.g. external inspectional observations, 483s, warning letters, recalls, industry or regulatory trends, etc).  Disseminates relevant information to impacted groups.
• Reviews Hikma’s internal and external audit observations and CAPAs and determines solutions to compliance knowledge gaps.
• Represents Regulatory Compliance on the