Sr. Specialist, Regulatory Compliance

Job Title: Sr. Specialist, Regulatory Compliance

Location: Columbus, OH

Job Type: Full time

Req ID: 7497

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 Sr. Specialist, Regulatory Compliance to join our team. In this role, you will be responsible for Ensuring quality and compliance to domestic and international regulatory requirements through performance of internal and external audits and provides guidance and leadership to the site. Assists in the establishment of Company compliance strategy and facilitates resolution and prevention of compliance risks.

Key Responsibilities:

• Schedules and conducts internal audits of manufacturing operations, laboratories, warehouses, and support departments to ensure compliance with company, domestic (FDA, DEA, etc), and international regulatory requirements. Activities include:
  • Evaluating systems, processes, and practices for compliance to regulatory requirements.
  • Conducting meetings with senior management to discuss audit observations and responses.
  • Assesses internal audit observations for potential impact to other areas within the organization and develops action plans to address.
  • Determining acceptability of responses, provides recommendations when appropriate, and monitors CAPAs to completion.
  • 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.
  • Preparing (with limited guidance) the annual internal audit schedule. Assesses regulatory environment, internal risks and industry trends/best practices for development of the internal audit schedule.

• Partners with and influences Operations, Laboratories, Warehousing & Distribution, and Quality Assurance to ensure consistent compliance approach throughout the organization and support quality compliance adherence. Activities include:
  • Leading cross-functional project teams (managing scope, deliverables, timelines, and team members).
  • Interpreting and communicating domestic and international regulatory requirements (e.g. 21 CFR Parts 4, 11, 210, 211, 820, EMA, WHO, etc).
  • Acting as resource for inquiries.
  • Serving as Regulatory Compliance representative on teams or in meetings.
  • Serving as subject matter expert (SME) in the development of GxP training programs.

• Leads 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.
  • Hosting customer inspections.
  • Leading audit room or ready room operations.
  • Obtaining and reviewing requested documentation.
  • Preparing SMEs prior to interactions with authorities; and accompanying inspectors during facility tours.
  • Leading development of audit responses including review with senior leadership.
• Prepares (with limited guidance) field alert reports and manages recall activities.
  • Schedules, coordinates, and conducts audits of suppliers who provide GMP related materials and services to ensure supplier compliance with domestic, international, and company requirements.

Skills:

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 regulatory inspectors, who have different personalities, styles, expectations, and motivations.

• Physical Demands/Surroundings
  • 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
  • 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
  • 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 audit schedules, analyzes audit results, and has authority to determine direction and move forward to implementation. Management consultation is required if there is any question regarding correct path forward.
  • 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.
• This role must engage with all other functional areas and must network and leverage relationships in Quality & Compliance locally, regionally, globally, and with external business partners as appropriate.
• Interacts with individuals within the organization who have different personalities, styles, expectations, and motivations.
• Leads cross-functional teams and/or initiatives. This role mentors others, including people leaders and individual contributors in other areas, as well as, other Regulatory Compliance specialists.

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.
  • Five (5) years of pharmaceutical/regulated industry operations or quality experience required.
  • Demonstrated proficiency in Regulatory requirements (cGMPs, DEA) and compliance including demonstrated knowledge of regulatory auditing principles.
  • 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.
  • Experience leading projects.

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.

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