Technical Lead - Quality and Regulatory IT Systems

Company: Akorn, Inc.
Location: Lake Forest
Posted on: April 5, 2021

Job Description:

Technical Lead - Quality and Regulatory IT Systems Lake Forest Job Description SUMMARY:
Lead - Quality and Regulatory IT Systems is a strategic, enterprise role that is responsible for driving projects and managing platform operations across the organization to maximize the value of IT technology investments. Through direct collaboration with the Quality organization, the incumbent will define, develop, and deliver efficient solutions that maximize business value. He/she will be recognized as a key contributor to the Quality and IT programs with a mindset that focuses on the key areas of people, process and technology in order to drive business transformation.


ESSENTIAL FUNCTIONS:

• Drive the successful adoption of the Veeva quality platforms across the Akorn enterprise utilizing knowledge of the Veeva Vault platform and expertise of pharmaceutical quality operations.
• Map business processes to capture business requirements and perform fit-gap analysis to the harmonized future state. Conduct root cause analysis and identify solutions to close gaps.
• Facilitate continuous improvement opportunities in order to optimize processes and remove inefficiencies, aligning Akorn towards industry best practices.
• Lead as a key member of the Veeva implementation program, acting as a change agent and liaison between key business units (QA, DI, QC, RA, and R&D, internal IT teams and vendor resources.
• Drive release management for Veeva Vault software releases, including risk assessment, testing coordination, and post release configuration items.
• Function as the primary contact and escalation point for the Veeva platform issues in support of local site business administrators and end users.
• Assess various quality and regulatory applications and practices (e.g., training, RIM, pharmacovigilance, and other as needed) to assess effectiveness and develop roadmap based on impact and priority. Lead initiatives to enhance associated business processes and align to corporate standards Qualifications MINIMUM QUALIFICATIONS:
  
  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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  • Deep knowledge of computer systems validation and Part 11 requirements.
  • Sound understanding of quality and manufacturing systems and processes by working within a quality operation.
  • Customer-oriented attitude with strong written and verbal communication skills.
  • Sound understanding of pharmaceutical quality, manufacturing and associated regulations.
  • Ability to work independently and collaboratively in a matrixed, team environment consisting of internal and external team members.
  • Demonstrated ability to breakdown current state and design efficient and effectively streamline business processes.
  • Ability to apply deductive reasoning and analytical thought to understand complicated issues.
  • Excellent planning and organization skills including the ability to manage deadlines and deliver on time with high quality output.
  • Focused decision-making with goal of improving business outcomes.
    EDUCATION AND EXPERIENCE:
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    • Bachelor's degree in information technology or scientific discipline with minimum of 5 years' experience in biotechnology, pharmaceutical or other regulated industry.
    • Strong knowledge of Veeva Vault platform with experience implementing QMS & Change Control, QualityDocs, RIM, Training, Safety, etc. Veeva certifications is a plus.
    • Experience with system design and configuration, testing, training, and change management.
    • Demonstrated experience in business analysis and project management within a best practice, SaaS managed service model.
      
      PHYSICAL DEMANDS, MENTAL REQUIREMENTS, AND WORK ENVIRONMENT
      The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
      
      This position requires prolonged sitting. Additionally, requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment. Requires normal range of hearing and vision to record, prepare and communicate appropriately. Additional physical and mental requirements include:
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      • Follow all applicable safety guidelines/rules. Use required PPE equipment when necessary.
      • Safety glasses, lab coats and close-toed shoes are required in all laboratory areas.
      • Additional safety equipment such as respirators, face shields, or safety shoes etc. may be required for specific tasks Company Overview Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies. EEO Statement Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

Keywords: Akorn, Inc., Lake Forest , Technical Lead - Quality and Regulatory IT Systems, IT / Software / Systems , Lake Forest, California