Technical Lead - Quality and Regulatory IT Systems
Company: Akorn, Inc.
Location: Lake Forest
Posted on: April 5, 2021
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
- 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
- Drive release management for Veeva Vault software releases,
including risk assessment, testing coordination, and post release
- 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
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
- Deep knowledge of computer systems validation and Part 11
- Sound understanding of quality and manufacturing systems and
processes by working within a quality operation.
- Customer-oriented attitude with strong written and verbal
- 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
- 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
- Focused decision-making with goal of improving business
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
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
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