Specialist, Regulatory Compliance

Job Title: Specialist, Regulatory Compliance

Location: Columbus, OH

Job Type: Full time

Req ID: 8012

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 750 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 8,500 employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Specialist, Regulatory Compliance to join our team. In this role, you will be responsible for ensuring quality and compliance to GMPs, controlled substance handling regulations, and international regulatory requirements through performance of internal and external audits. Collaborates with cross-functional teams to drive tactical solutions to assigned areas of focus. Assists in the establishment of Company compliance strategy and facilitates resolution and prevention of compliance risks.

Key Responsibilities:

• Performs internal audits of manufacturing operations, laboratories, warehouses, and support departments to ensure compliance with domestic (DEA, FDA, etc), international, company, and corporate regulatory requirements. Activities include:
  • Evaluating systems, processes, and practices for compliance to regulatory requirements.
  • Conducting meetings with management to discuss audit observations and responses.
  • Partnering with audited functional/operational area to perform root cause analysis of non-compliance in order to determine CAPA. Provides regulation based recommendations and support as needed to resolve quality/compliance issues. Evaluates effectiveness of CAPAs generated from internal audits.
  • Obtains mutual agreement of CAPAs and facilitates to completion.
  
  

• Partners with Operations, Laboratories, Warehousing & Distribution, and Quality Assurance to ensure consistent compliance approach throughout the organization and support quality compliance adherence. Activities include:
  • Acting as Regulatory Compliance subject matter expert (SME) on cross-functional teams or in meetings.
  • Acting as resource for inquiries.
  • Serving as an SME in the development of GxP training programs.
  
  

• Performs routine and Pre-approval Inspection (PAI) readiness activities (customer and regulatory) to ensure a consistent approach before, during, and after inspections. Activities include:
  • Evaluating systems, processes and documentation for compliance to customer or regulatory requirements.
  • Conducting meetings with area management to discuss preparation activities and documentation requests.
  • Leading ready room operations.
  • Obtaining and reviewing requested documentation.
  • Preparing SMEs prior to interactions with authorities; and accompanying inspectors during facility tours.
  • Partnering with area management to develop audit responses.
  
  

• Oversees Regulatory Compliance product registration activities and provides tactical support for activities to maintain license to operate. Activities include:
  • Developing documentation for international regulatory submissions.
  • Authoring the Site Master File
  • Authoring and publishing company metrics
  • Performing regulatory compliance assessments and routing/tracking supplier qualification documents.
  • Creating and monitoring supplier AMPLs.
  • Facilitating supplier QAA negotiations.
  • Supporting day-to-day DEA documentation activities such as reviewing and signing DEA Form 222s, order processing.
  • Assisting in the preparation of DEA quota applications.

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:

• Minimum:
  • BA/BS, preferably in scientific, engineering or quality field, is required. Other BA/BS programs may be considered provided that the applicant has successfully completed fundamental college math and science coursework.
  • Three (3) years of pharmaceutical/regulated industry operations or quality experience required.
  • Demonstrated proficiency in Regulatory requirements (cGMPs, DEA) and compliance.
  • Demonstrated proficiency in computer skills as a business tool, including work experience with Microsoft applications (Word, Excel, PowerPoint, Outlook) and site systems (SAP, Trackwise, QSDB, and ARQ document management system).

Preferred:

• • Experience in pharmaceutical manufacturing, packaging, and/or quality preferred.
  • Experience and inspection interaction with State and Federal regulatory officials (i.e. FDA, DEA, or Board of Pharmacy) preferred.
  • Auditing certification (ASQ, ISO or other recognized institute) preferred.

Skills:

• • Must pass a drug screen prior to starting employment.
  • Flexibility required meeting the different business units' schedules and needs.
  • Work pace may vary from day to day.
• Visual Demands
  • Vision clarity with or without correction to read handwritten data, computer-generated documents, and judge distance.
  • Perceiving sound by ear is necessary for conversational purposes and to be aware of machine operations, and/or office environment.
• Temperaments/Mental Requirements
  • This role has a high degree of freedom to initiate the thinking process; tasks involved are somewhat repetitive.
  • High degree of mental effort required to interpret regulations, make decisions, and provide direction to the organization.
  • 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 complete documentation.
  • Ability to work independently, in a team atmosphere, and with employees at all levels.
  • Alertness and awareness of the general work area is necessary at all times.
  • Long and short-term memory is utilized for procedures and processes.
• Level of Proficiency
  • Decision making can significantly impact compliance, including cost of non-conformance, potential regulatory citations, fines, and recalls. Decisions that can be supported by regulations, company procedures are within the specialist’s authority. Peer and supervisor consultation is encouraged if there is any question pertaining to correct path forward. Management must be consulted if a decision cannot be made based on documents noted above.
  • Converse in Standard English at high school graduate level, and comprehend written communication for basic instructions, safety rules, and procedures at high school graduate level.
  • Knowledge and execution of and compliance at all times with departmental safety, quality, operational procedures, regulatory, and company policies and procedures are required.
  • Demonstrated computer skills.
• Attendance/Schedule
  • Daily attendance and punctuality must be maintained in accordance with policies and procedures.
  • A typical work schedule is 8 hours per day.
  
  

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 3% 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.

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.