LakeForestRecruiter Since 2001
the smart solution for Lake Forest jobs

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.
    --
    • 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:
      --
      • 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:
        --
        • 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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other IT / Software / Systems Jobs


Application Developer
Description: OverviewThe Application Developer will be responsible for the overall coding and design of technology solutions that address the business needs of PennyMac.Job DescriptionUtilize Minimum requirement to (more...)
Company: PennyMac
Location: Moorpark
Posted on: 04/18/2021

Technical Project Manager (Project Hire)
Description: Job Summary: This is a project hire position for up to 2 years from date of hire br br The Customer Relationship Management team is responsible for creating and cultivating direct-to-consumer (more...)
Company: The Walt Disney Company (Corporate)
Location: Los Angeles
Posted on: 04/18/2021

Information Systems Security Manager (ISSM)
Description: Description SAIC currently has a career opportunity for a Senior Information System Security Manager ISSM in El Segundo, CA. Description: The Information Systems Security Officer ISSM will have responsibility (more...)
Company: SAIC Corporation
Location: El Segundo
Posted on: 04/18/2021


SENIOR SOFTWARE TEST ENGINEER
Description: Position Title: Senior Software Test Engineer Position Description: Protingent has an exciting direct hire opportunity with our client in El Segundo, California. Job Requirements: Lead design and development (more...)
Company: Protingent
Location: El Segundo
Posted on: 04/18/2021

Sr. Staff Data Analyst (Consumer Web Products)
Description: WHO WE ARE:Voted one of the Top 100 Fastest Growing Companies in the Bay Area for 2020, Freedom Financial Network is a family of companies that takes a people-first approach to financial services, using (more...)
Company: Freedom Financial
Location: Los Angeles
Posted on: 04/18/2021

Mobile Cosmetologist/Hairstylist
Description: Los Angeles, CA Join the top rated on-demand wellness platform in the world Soothe connects massage therapists, cosmetologists, and estheticians directly to clients via our app, making the wellness industry (more...)
Company: Soothe
Location: South Pasadena
Posted on: 04/18/2021

Linux Systems Administrator II
Description: Raytheon currently has an exciting IT position available that supports the Raytheon mission of making the world a safer place.We are currently seeking a Linux / Unix Systems Administrator that will be (more...)
Company: Raytheon Technologies
Location: El Segundo
Posted on: 04/18/2021

Software Developer - Android
Description: Vynyl delivers high-fidelity software, design, and product solutions for clients across a wide spectrum of industries and needs. Recent projects include applications that: power the 1 snow sports app, (more...)
Company: Vynyl - High-Fidelity Software and Design
Location: Los Angeles
Posted on: 04/18/2021

Senior Software Engineer
Description: Lead Software Engineer Must have strong AWS and Node architecture experience. PythonGo a huge plus. Responsibilities Responsible for the analysis, design, development and delivery of software solutions. (more...)
Company: Prosum
Location: Los Angeles
Posted on: 04/18/2021

Entry Level Software Engineer
Description: Revature, a fast growing employer of emergency technology is looking for entry level candidates with a curiousity towards IT to train as Software Engineers.What We Are Looking For ul li College degree (more...)
Company: Revature
Location: Lakewood
Posted on: 04/18/2021

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Lake Forest RSS job feeds