Sr. Manager, External Quality

Location
Cambridge, MA, United States
Posted
Aug 20, 2018
Ref
472186
Discipline
Quality, Quality Control
Hotbed
Genetown
Required Education
Associate Degree
Position Type
Full time
Title:
Sr. Manager, External Quality

Company:
Ipsen Bioscience, Inc.

Job Description:

Summary:

Under the direction of the Head of Quality Operations, the Manager/Senior Manager QA, External/CMO will provide Quality oversight of cGMP external manufacturing operation activities. The Sr. Manager will support Quality relationship management including oversight of process performance metrics, investigations, change controls, product disposition and Quality Management Systems, as needed. This role may require some travel.

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Provide Quality oversight of cGMP external manufacturing operations.
  • Lead Quality focused meetings between CMOs and partners.
  • Provide support for process performance qualification activities including document review and approval.
  • Provide Quality support for the release of clinical materials.
  • Provide Quality oversight of transfers to contract manufacturing organizations.
  • Perform audits of CMOs, as needed.
  • Provide Quality guidance and support for investigations and change controls.
  • Monitor performance metrics and drive continuous improvement of CMOs and internal processes.
  • Supervise Quality associates and provide coaching, mentorship and support of development plans.
  • Travel, as needed to contract manufacturing organizations to support company's products.
  • Complies with all laws, regulations and policies that govern the conduct of Ipsen U.S. staff


Qualifications

Education
  • B.S. Degree, in Life/Health Sciences, preferred.

Experience
  • A minimum of 10 years in the Pharmaceutical Industry with a significant portion in Quality.
  • Experience working with external partners (e.g. contract manufacturing organization, contract laboratories and suppliers)
  • Experience with sterile product manufacturing preferred.
  • Understanding of and ability to apply pharmaceutical/biotech cGMP regulations and guidance using a risk-based approach

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.