QA Training Manager

Location
Cambridge, MA, United States
Posted
Aug 25, 2018
Ref
R-00666
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
QA Training Manager

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

This position is responsible for the quality oversight of the GXP Training Programs at Ipsen Cambridge Manufacturing US. The successful candidate will maintain a robust and compliant training program that supports the strategic vision and daily GXP operational activities at the Ipsen Cambridge Manufacturing -US (ICMUS) site. This includes shaping the overall GXP training program, administering ComplianceWire, teaching Quality System classroom trainings, and continually improving the Training Program. The candidate should be expected to leverage training, experience and technical knowledge to all GXP groups on a routine basis, influencing a fast-paced dynamic environment to address quality concerns appropriately.

Essential Functions

Training Program Owner/Subject Matter Expert:
  • Shape the overall training program to provide a robust, compliant, streamlined training program that supports GXP operations and can withstand the rigor of regulatory inspections
  • Design and administer the electronic training management system (ComplianceWire used at ICMUS). This will include structuring ComplianceWire using a hierarchy that is user friendly and supports the training needs of the site.
  • Develop and implement a Train the Trainer Program
  • Instruct and administer Quality Systems Classroom training
  • Ensure a robust on-boarding program
  • Evaluate the training program in order to ensure continuous improvement


Inspection Readiness:
  • Participate in Inspection Readiness activities to ensure the training program is continuously inspection ready
  • Support Audit/Inspection activities by being the training subject matter expert and supporting back room inspection operations


Cross Functional Quality Systems Responsibilities:
  • Participate in internal audits as needed
  • Provide training metrics for global and site KPIs
  • Participate in Quality Council Meetings as needed in regards to Training Program performance
  • QA Approver for Training related Quality Incidents (deviations/unplanned events), CAPAs and Change Controls


In his/her domain of activity, to respect the regulation, to apply the IPSEN good practices and standards, and the Company procedures set up on the site.
  • Participate in the EHS training, as proposed or requested on the site.
  • Contribute to reduce the environmental impact of the activities on the site.
  • Inform his/her superiors of any changes affecting the workstation, in order to improve the EHS on site.


Qualifications

Education & Certifications
  • BA/BS degree in Biochemistry (or a related field)

Experience

Technical Experience:
  • 10 + years of experience in a GMP environment
  • 2+ years working with GXP training programs
  • Ability to analyze, trend, report and present data
  • Veeva Vault and TrackWise experience is a plus

Additional Qualifications:
  • Candidates must be self-motivated, and have a strong attention to detail with the ability to multitask
  • Excellent written and oral communication with exceptional organizational skills
  • Demonstrated ability to work in a team environment as well as manage projects independently

Core Competencies
  • Ability to work with minimal supervision as well as in a team environment
  • Strongorganizational and presentation skills
  • Strong relationship, teambuilding, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes:
  • Personal flexibility and a proactive orientation;
  • Ability to handle multiple priorities.
  • Ability to work under time and resource constraints.
  • Commitment to excellence and high standards.


Communication & Interpersonal Skills
  • Written: excellent
  • Verbal: excellent
  • Interpersonal: excellent


Other
  • Ability to work weekends pending business needs


Essential Functions - Physical Demands & Working Conditions
  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
  • Regularly required to operate standard office equipment (computer, copy/fax machine, etc.)
  • Ability to work on a computer up to 7 hours a day and occasionally sit or stand or walk for long periods of time
  • Ability to work in a dynamic environment which can include but not limited to office, laboratories, manufacturing, off-site venues, etc. depending on functional role.
  • Standard office environment. Potential interaction with laboratory environment with exposure to chemicals.
  • Close vision required for computer usage.
  • Occasionally required to stoop, kneel, climb and lift up to 30 pounds.
  • Required to consistently and properly use Personal Protective Equipment in keeping with Ipsen safety policies and practices.


Environmental, Health & Safety Requirements
  • Comply with all corporate and facility Environmental, Health and Safety policies and procedures. Attend all mandatory EH&S meetings and complete all EH&S training requirements.
  • Intervene in potentially unsafe situations and report any incident, unsafe acts, conditions or equipment. Report any emergency situation (medical emergency/chemical spill/security concern) by following established emergency programs and procedures.


The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Bioscience, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Bioscience, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.