What are the responsibilities and job description for the Specialist, Regulatory Compliance position at Hikma Pharmaceuticals?
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 :
Preferred :
Skills :
What We Offer
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.
