• Senior Specialist , Supply Chain Compliance Jobs in United States Of America - 25277622

  • Boehringer Ingelheim India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 1 - 6 Years
  • Posted : above 1 month

Job Description:

We are continuing our rapid growth, investing over $200m into the expansion of our capacity and capabilities, and creating approximately 200 new jobs

Driving this growth is an exciting pipeline of multiple Boehringer Ingelheim novel biologic entities (NBEs) and biosimilars, as well as, a growing diverse portfolio of therapeutics we develop and manufacture for other leading pharma and biotech companies This includes multiple commercial product launches planned over the next couple of years, for which we can tap into Boehringer Ingelheims unique experience of having brought 30 biologics to market globally

Leveraging our diverse talent pool, we are also driving technology and innovation globally, through major investment and collaborations into next generation manufacturing platforms and technologies, which may change how biologics will be made in the future

Whether we work on our own products, help partners to bring their products to market or innovate new technologies and approaches - Everything we do, we do to help patients!

Description

The SR Specialist works under limited direction This job executes several areas of manufacturing compliance (Deviation/Corrective and Preventative Actions (CAPA), Change control, Project management and trending of key performance indicator metrics This job collaborates closely with Quality, other functional areas as required and Supply Chain groups to ensure investigations are complete and scientifically sound, change controls are clear and complete, and ensure that new products are introduced into manufacturing in a compliant way Additionally, this job is responsible for Training Compliance in the department including monitoring of KPIs, curriculum assignment and updates This job independently drives improvements of Supply Chain through specific programs and projects as aligned with Director SR Specialist acts as a key liaison for Quality Compliance in preparation for Supply Chain Management (SCM) and Logistics audits

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success We realize that our strength and competitive advantage lie with our people We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance Our competitive compensation and benefit programs reflect Boehringer Ingelheims high regard for our employees

Duties & Responsibilities

Training Compliance
In collaboration with Quality and Training, evaluates and assigns Curricula in the department; Drives Curricula review by each area and monitors Training Completion of each area Works with SCM and Logistics to develop and assign new trainings, update and eliminate as needed Acts as a key coach to the department
Investigations and corrective actions
Thoroughly investigates deviation events utilizing root cause analysis techniques Utilizes technical writing strategies to ensure content is clear, concise, and complete Leads team to evaluate pertinent aspects involved in determining deviation scope, impact, and to perform necessary evaluations to support conclusions Ensures corrections are initiated to address root cause and contributing causes discovered during investigation Works with team in identifying and assigning CAPA within department Monitors and coaches team through execution to meet target completion
Inspection Preparation and Readiness
Participates in maintaining inspection readiness within Supply Chain & Logistics
Generates play books for complex deviations, CAPA, and change controls
Proposes and executes compliance process and procedural changes to reduce deviations
Implements corrective actions along with SCM Heads
Develops and provides hands-on training / guidance on SCM and Logistics compliance, and reinforces cGMPs to increase quality and compliance knowledge throughout SCM & Logistics organization
Departmental Objectives
Collaborates within department and cross-functionally to meet set objectives
Represents Supply Chain Compliance on cross functional teams and gains alignment on day to day compliance issues
Manages projects of SCM / Quality initiatives
Successfully lead the SCM team to overcome roadblocks to meet project time lines

Requirements

Bachelors degree from an accredited institution in Business Administration, Biopharmaceuticals, and/or Economics
Minimum of two (2) years of professional experience in SCM
Experienced with leading investigations, writing deviation reports, owning change controls, and corrective actions
Experienced with leading cross functional teams and driving results Able to work under pressure and experienced meeting multiple deadlines
Possesses knowledge of cGMP systems and of regulations
Has knowledge of industry and business principles
Has expanding knowledge of deviation/CAPA, change control, project management, and audits/inspections
Understands Supply Chain and Manufacturing processes
Demonstrated ability to run effective meetings
Skilled at technical writing, creating and delivering presentations, and providing training and guidance to others
Managed multiple assignments and processes
Developed practical and thorough solutions for complex issues
Critical thinking skills
Organizational, technical writing and presentation skills
Strong ability to communicate with technical and management staff cross functionally
Detailed technical understanding of bioprocessing unit operations
Strong ability to influence in a team environment and collaborate with peers
Project management skills
Strong ability to develop solutions to complex issues
Expertise with leading investigations, writing deviation reports, owning change controls, and corrective actions
Expertise with leading cross functional teams and driving results Able to work under pressure and experienced meeting multiple deadlines
Possesses knowledge of cGMP systems and of regulations
Has knowledge of industry and business principles
Has expanding knowledge of deviation/CAPA, change control, project management, and audits/inspections
Understands Supply Chain and Manufacturing processes
Skilled at technical writing, creating and delivering presentations, and providing training and guidance to others
Adhere to Quality System Policies at BI and Fremont

Eligibility Requirements

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 31st May 2020

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