Manager/Sr. Manager, QA Validation

Location
Cambridge, MA, United States
Posted
Aug 07, 2018
Ref
478002
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
Manager/Sr. Manager, QA Validation

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Under the direction of the Head of Quality Operations the Manager/Senior Manager, QA Validation will proactively lead and manage Quality Validation staff at the Cambridge, MA manufacturing site to ensure qualification and validation of equipment, facilities, utilities, automated systems and cleaning procedures are carried out in accordance with Ipsen procedures and policies, global cGMP and best industry practices. The Manager/Senior Manager will assure process validation and QC Equipment validation activities are cGMP compliant.

Essential Functions
  • Lead the preparation, revision and approval of the site validation master plan (VMP).
  • Lead and manage the development of Validation Plans to support the Site Master Plan, as applicable.
  • Assure site subject matter experts on all validation and qualification activities are appropriately led, managed and trained at all times.
  • Lead the validation efforts for all Strategic Projects on site. Assign tasks, as appropriate.
  • Manage the preparation, review and/or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, (manufacturing processes) and cleaning processes, as well as providing regulatory guidance and auditing for Quality.
  • Manage the review and approval of third party generated protocols and reports
  • Manage the review, execution and approval of site acceptance testing (commissioning) activities
  • Manage deviations and investigations as well as other quality systems impacting QV
  • Manage and assess change control activities, as appropriate
  • Perform periodic reviews of systems in order to maintain validation status
  • Lead and manage a team of individual contributors that includes project managers, validation engineers, calibration technicians, external contractors/consultants and administrative staff as appropriate
  • Manage a site budget
  • Support cGMP inspections by health authorities


Qualifications

Education & Certifications
  • BS degree in Science or Related Fields or equivalent past experience

Experience
  • 8+ years in a Senior Validation Role within the Pharma industry or equivalent, 5 years in leadership role
  • Expertise with Process Equipment, Utilities and Automation.
  • Expert in Data Integrity and Process Validation, Cleaning Validation, Computer System Validation, Good Automated Manufacturing Practices, 21 CFR Part 11 and understanding of global regulations and guides.
  • Deliver on validation timelines relating to Strategic Projects on site.


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.