Title:  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 global Regulatory Intelligence subcommittee, Quality System Compliance and Performance Board and other teams as applicable.
• Acts as a resource for inquiries.

• Partners with and influences Operations, Laboratories, Warehousing & Distribution, and Quality Assurance to ensure consistent compliance approach throughout the organization and support quality compliance adherence.  
• Leads cross-functional project teams (managing scope, deliverables, timelines, and team members).
• Supports regulatory inspections, customer and internal audits as needed.
• Serves as the Regulatory Compliance representative on teams or in meetings.

• Communications:

• • This role must engage with all other functional areas and must network and leverage relationships in Training or Quality & Compliance locally, regionally, globally, and with external business partners as appropriate. 
  • Leads cross-functional teams and/or initiatives.  This role mentors others, including people leaders and individual contributors in other areas.
  • Decision making can significantly impact compliance, including cost of non-conformance, potential regulatory citations, fines, and recalls.  Decisions made can also set a precedent; therefore, critical assessment of all possible solutions is required to prevent unnecessary actions.
  • Interacts with individuals outside the organization including customers and regulatory authorities.

Qualifications:

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:

• BA/BS, preferably in scientific, quality, or education field, is required.  Other BA/BS programs may be considered provided that the applicant has successfully completed fundamental college math and science coursework.  Plus a minimum of five (5) years of pharmaceutical/regulated industry operations, quality experience, or demonstrated classroom teaching experience (middle school or above) required.
• Associate’s degree, preferably in scientific, quality, or education field, is required.  Other Associate’s degree programs may be considered provided that the applicant has successfully completed fundamental college math and science coursework.  Plus a minimum of five (7) years of pharmaceutical/regulated industry operations, quality experience, or demonstrated classroom teaching experience (middle school or above) required.
• Demonstrated proficiency in regulatory compliance requirements (GMP, DEA). 
• Demonstrated proficiency in computer skills as a business tool, including work experience with Microsoft applications (Word, Excel, PowerPoint, Outlook) and site systems (LMS and Veeva Vault document management system). 

Preferred Qualifications:

• Experience developing and/or delivering pharmaceutical manufacturing, packaging, and/or quality control training preferred.
• Experience developing and/or delivering training for adult learners using different software applications and methodologies. 
• Experience leading projects.
• Experience reviewing and assessing regulations or guidances.
• Strong attention to detail and ability to problem solve.
• Strong written and verbal communication skills are necessary to interact with customers, co-workers and to facilitate training sessions.
• Ability to work independently, in a team atmosphere, and with employees at all levels.
• Complexity of job is best described as high due to the difficulty of interpretation of numerous guidelines and regulations which are then incorporated into the philosophies of the site.
• Makes risk-based assessments to recommend training curriculum philosophy, solutions to reduce risk, and has authority to determine direction and move forward to implementation.  Management consultation is required if there is any question regarding correct path forward.
• Knowledge and execution of and compliance at all times with departmental safety, quality, operational procedures, regulatory, and company policies and procedures are required.

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

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that 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.

Equal Opportunity Employer:

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.

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