Manager, QC Compliance

Location
Cambridge, MA, United States
Posted
Aug 07, 2018
Ref
478636
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Manager, QC Compliance

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Under the direction of the Head of QC, the QC Compliance Manager will be responsible for ensuring and enforcing group compliance to all laboratory, documentation, procedural and regulatory requirements. The QC Compliance Manager will also be responsible for leading a team of analysts in various QC documentation roles.

Essential Functions

Responsibilities will include, but are not limited to, the following:
  • Oversee a team of analysts who are responsible for all aspects of laboratory data review (technical and compliance), authoring laboratory investigations and certificates of analysis
  • Oversee sample management process in the laboratory
  • Serve as the QC lead for data integrity projects
  • Ensuring 100% inspection readiness
  • Develop, drive and maintain KPI's and metrics for the QC lab
  • Responsible for trending OOS, OOT and invalids and implementing process improvements
  • Monitor and ensure timely closure of all laboratory investigations, OOS, OOT, invalids and CAPA's
  • Monitor and ensure all deliverables for batch release and stability are meet
  • Drive process improvement projects for the QC lab and organization
  • Review and approve investigations, specifications and other GMP documentation
  • Represent QC at cross functional planning meetings


Qualifications

Education & Certifications
  • BS/ MS degree in the life or physical sciences with a preference for a concentration in microbiology, analytical chemistry or pharmaceutical chemistry.


Experience
  • 8-10 years of experience working in a GMP laboratory
  • 2+ years of management experience in a laboratory setting preferred
  • Experience with Waters Empower Software and TrackWise preferred
  • Thorough understanding of cGMP's and good documentation practices
  • Proven leadership skills and demonstrated results driver


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


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.