BostonRecruiter
the smart solution for Boston jobs

Senior Manager / Associate Director, External Quality Operations

Company: Homology Medicines
Location: Bedford
Posted on: November 14, 2018

Job Description:

Employer Homology Medicines Location Bedford, Massachusetts (US) Posted Nov 01, 2018 Discipline Quality, Quality Assurance Required Education Masters Degree/MBA Position Type Full time You need to sign in or create an account to save Senior Manager / Associate Director, External Quality Operations Location: Bedford, MA Job Code:ADG0033-18 Job Summary The Senior Manager , External Quality Operations will be responsible for managing external quality operations of gene therapy products.. This role includes ownership of the external disposition process, QA liaison to contract manufacturing organizations (CMO), contract testing labsand distribution centers including review and approval of quality system records including, but not limited to batch records, deviations and qualifications. The individual will also work cross-functionally to develop, implement, and improve processes to support the start-up and operation of internal GMP manufacturing capabilities. Essential Functions and Duties Ownership of the batch disposition process for externally manufactured products Serve as primary liaison to CMOs, CTLs, and distributors Oversight of quality activities associated with manufacturing and testing of clinical materials Batch record review and approval Tech Transfer and Validation support Review and approval of QC activities including: testing, method qualification/validation, and stability protocols/reports Support regulatory authority inspections and partner audits QA oversight of quality system records including: Deviation, CAPA, Change Control, and Investigations Support establishment and management of the quality metrics Skills and Experience Bachelor's degree in life sciences, engineering, or equivalent Minimum 8 years of experience in the pharmaceutical or biotech industry in QA operations and direct experience working with Quality Systems, specifically batch record review and disposition Ability to lead, problem solve, and work autonomously in a dynamic manufacturing environment Ability to apply a phase appropriate, risk-based approach to QA operational decisions Comprehensive knowledge of GMP regulations and guidelines Experience with tech transfer, qualifications and validations Direct experience with biologics Drug Substance and Drug Product manufacturing Excellent technical, organizational, communication, and interpersonal skills are essential Flexibility to accommodate to rapidly changing priorities and deadlines Auditing experience a plus Interested candidates should forward a cover letter and Resume / CV to ***************************** Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases. More searches like this Quality jobs in Bedford Quality Assurance jobs in Bedford

Keywords: Homology Medicines, Boston , Senior Manager / Associate Director, External Quality Operations, Executive , Bedford, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Product Marketing Manager
Description: 10/09/2018 Requisition ID 14444BR QuestionName : Duties Responsibilities , AnswerValue : If you thrive on solving challenges and love learning about the latest innovative technologies, Teradyne is (more...)
Company: Teradyne
Location: North Reading
Posted on: 12/11/2018

DIRECTOR OF NURSING / OR-PERIOPERATIVE NURSING DIRECTOR
Description: Acute Care Facility in Boston is seeking a Nurse Director to oversee its Perioperative Service Line. This 170 bed non-profit, community teaching hospital has a long history of meeting the health care (more...)
Company: Aureus Medical Group
Location: Jamaica Plain
Posted on: 12/11/2018

Robotics Project Manager
Description: Robotics Project Manager 04/04/2018 Requisition ID 13875BR Duties Responsibilities Energid Technologies develops advanced software and robotic systems for the aerospace, agriculture, manufacturing, (more...)
Company: Teradyne
Location: Bedford
Posted on: 12/11/2018


Office Manager for Financial Firm
Description: Office Manager for Financial FirmOur client, a financial services firm in Downtown Boston, is looking to hire an organized Office Manager
Company: Hollister Staffing, Inc.
Location: Boston
Posted on: 12/11/2018

Nurse Manager
Description: Position No. 1171WNM Req No. 18-0878 Title Nurse Manager City E. Bridgewater Pay Range 28/hr Scheduled Hours 40 Schedule Mon - Fri 8a-4p Company Info Schedule: Mon - Fri 8a-4p Join BAMSIs growing workforce (more...)
Company: BAMSI
Location: East Bridgewater
Posted on: 12/11/2018

IT Project Manager
Description: Let companies apply to you, not the other way around. Sign up with Hired to get access to thousands of companies currently hiring IT Project Managers. br The IT Project Manager supervises every aspect (more...)
Company: HIRED
Location: North Easton
Posted on: 12/11/2018

Bilingual OB Fulfillment Manager (2nd Shift)
Description: Potpourri Group Inc., referred to as PGI , was founded in 1963, publishing a single consumer catalog title. New brands were added through internal development and acquisitions so that today PGI has grown (more...)
Company: Potpourri Group
Location: Littleton
Posted on: 12/11/2018

Dining Services Director
Description: Dining Services Director Location Brightview Canton City Canton State MA Apply Now Position Type: FTR- Full Time Shift: 8:30a-5:00p Other Shift: The Dining Services Directors at Brightview communities (more...)
Company: Brightview Senior Living
Location: Canton
Posted on: 12/11/2018

Assistant Front Office Manager
Description: Housed in the stately limestone building that was once home to the city's police headquarters, Loews Boston Hotel offers an unforgettable blend of historic charm, sophistication and authentic New England (more...)
Company: LOEWS HOTELS
Location: Boston
Posted on: 12/11/2018

Construction Project Manager - Home Reconstruction
Description: Residential Capital Management Resicap is the leading vertically integrated solution for institutional owners of single-family residential assets in the United States. Our services include asset acquisition/valuation, (more...)
Company: Ameritrust Residential Services
Location: Lowell
Posted on: 12/11/2018

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds