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CAREER OPENINGS


Director, Quality Operations

ID: 1642
Department: Quality
Location: Cambridge Headquarters
# of Openings: 1

Description

Director, Quality Operations

Functional area: Quality

 

Position description:

The Director of Quality Operations (Quality Assurance and Quality Control) will be responsible for overseeing current Good Manufacturing Practices (cGMP) of manufacturing, quality control testing, packaging and release activities of commercial and clinical trial materials conducted at Contract Manufacturing Organizations (CMO’s).  This is hands on Director level role centered on a risk-based program that assures compliance to US and international standards.   

This key individual will act as a subject matter expert on technical matters involving product related testing, disposition, quality investigations, cGMP compliance, and in business matters involving pharmaceutical operations. The incumbent will be tasked with strategic and operational responsibilities pertaining to Ironwood’s Global Quality System and an integral partner to Ironwood’s supply chain and pharmaceutical development teams.  This person must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building.  As Ironwood utilizes a virtual GMP CMC model, quality oversight of external vendors is a primary component of this position and requires approximately 15 % travel.   The position reports to the Head of Quality Operations.

 

Responsibilities:

  • Interacts internally and externally with executive- level management requiring negotiation of extremely difficult matters. 

  • Oversee the OOS/OOT, Deviation, CAPA, and Change Control processes.  Review and coordinate approval of all changes made to manufacturing and control processes including those that are initiated by partner Contract Manufacturing Organizations, Contract testing Labs, raw material and component suppliers.

  • Authoring, revision, review, and approval of product specifications

  • Approve master and executed production records for GMP manufacturing of investigational and commercial drug substance and product. 

  • Approval of analytical test methods that progress from development to the commercial arena

  • Author, review, and/or approve CMC sections of regulatory submissions for IND’s, CTA’s, NDA’s, Annual Product Reviews, as assigned.

  • Utilizing risk management principles manage product release activities for clinical and commercial materials

  • Prepare disposition statements of clinical (and commercial as needed) materials based upon the review of all pertinent records, CoC, and CoA for the approval and distribution of GMP materials. 

  • Prepare technical reports and communicate key findings.

  • Develop and negotiate Quality Agreements.

  • Oversight of GMP analytical release and stability testing programs at Contract Manufacturing and Contract Research Organizations

  • Analytical life-cycle management including method enhancements and associated analytical method validations and method transfers

  • Trending of analytical release and stability data for commercial drug substances and drug products

  • Oversight of the reference standard and reference materials programs that support both pipeline and commercial activities

  • Management of Laboratory Information Management System (LIMS)

  • Create audit plans, perform audits, and compile audit reports of contract manufacturing organizations to ensure those companies comply with cGMPs and regulations of applicable international authorities. 

 

Requirements:

  • 12+ years in a scientific discipline with pharmaceutical industry experience including cGMP Quality Assurance and Quality Control, and participation in regulatory agency inspections.

  • Leadership skills should include the ability to provide coaching and mentorship to group and/or team.

  • Over 5 years’ experience managing staff

  • Minimum of Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacy) or relevant field of study.

  • Experience communicating with both domestic and international contract manufacturing organizations and has an awareness of cultural diversity. 

  • R&D and Commercial pharmaceutical experience focused on small molecules.

  • Strong knowledge and experience with ICH, USP, 21CFR210, and 21CFR211.

  • Experience conducting contract manufacturing and analytical testing site assessments and cGMP audits, performing quality investigations, and management of quality systems. 

  • Ability to provide input to strategy for multifunctional integrated solutions.  

  • Experienced in preparing and negotiating quality agreements with CMOs. 

  • Experience providing Quality leadership on cross-functional project teams – resulting in alignment on priorities and actions utilizing good risk management principles.

  • Demonstrate strong organizational and interpersonal skills, building relationships with effective communication, influencing, conflict resolution, critical thinking and problem solving with a keen attention to detail.

  • Knowledge about European, Chinese, and Japanese regulations a plus.

  • Practical experience with Quality by Design is a plus.

  • Up to 15% scheduled travel may be required.

 

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.

 


Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.





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