QA Compliance Manager

Location
Cambridge, MA, United States
Posted
Aug 20, 2018
Ref
473636
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
QA Compliance Manager

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary:

Under the direction of the Senior Manager of Quality Systems, this position is responsible for the quality oversight of GMP Quality System activities at Ipsen Cambridge Manufacturing US. The successful candidate will support daily quality system activities in both commercial and clinical settings. 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. This includes appropriate interpretation and use of existing quality systems and practices.

Essential Functions:

Regulatory Surveillance:
  • Ensure robust, compliant and state of the art quality systems by monitoring changes in regulations and industry best practices and applying them to ICMUS quality systems
  • Provide leadership in shaping the Quality Systems that govern all GMP operations at Ipsen Cambridge Manufacturing US (ICMUS)


Self-Inspection:
  • Ensure compliance to local SOPs, global policies and applicable regulations by leading a vigorous internal auditing program
  • Liaise between ICMUS and other Ipsen sites globally to ensure alignment and sharing of best practices
  • Data Integrity:
  • Strong understanding of Part 11 and Annex 11 to administer programs that ensure the integrity of data generated, reported, captured and stored by electronic systems.
  • Deep understanding of Data Integrity principles to ensure the completeness, accuracy, consistency, and reliability of stored electronic and hard copy data


Inspection Readiness:
  • Ensure the site is inspection ready at all times
  • Evaluate regulatory inspection observations from other Ipsen sites to ensure those same gaps are addressed at the Cambridge site
  • Develop and deploy mechanisms to identify high risk issues and strategize on the best approach to present these issues to regulatory agencies during inspections.


Qualifications

Education & Certifications
  • BS degree or higher in Biology or Chemistry preferred
  • ASQ Auditing Certification in a plus


Technical Experience:
  • 10 + years of experience in a GMP environment
  • 5+ years of experience as a lead auditor
  • 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.