Manager Quality Assurance, GMP Pharma
Company: ViziRecruiter,LLC.
Location: Aliso Viejo
Posted on: September 17, 2023
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Job Description:
Industry: Medical Technology and Pharmaceutical Level: Full time
Compensation: Base Salary Range: $109,100 - $158,100 Overview
Position Summary The Quality Assurance Manager, GMP Pharma will
implement strategy and promote effective operation of the quality
assurance program for drug/device combination devices at Glaukos.
This person will work in close partnership with the Company's
R&D, Applied Research and Regulatory Affairs groups, and will
be the interface with the Quality groups at the CMOs, as it relates
to all quality assurance matters. Compensation Compensation for
each successful candidate will be based on several factors, which
may include qualifications, experience, education, talent
availability, and local market conditions. Range listed is not
inclusive of additional compensation such as bonus, equity, or
additional benefits Responsibilities Quality Assurance Drug
Combination Device Quality Management. Serve as GMP Quality Subject
Matter Expert for assigned drug programs. Follow established
quality systems procedures required for appropriate GMP compliance
including change control, deviations, complaints, training, etc.
Ensure supporting product, supplier and quality systems
documentation is maintained in accordance with company and industry
standards. Performance Perform quality assurance activities (such
as validation protocol/report review and approval, specification
review and approval, batch record review and release, etc.) to
ensure timely delivery of DS, DP and finished (packaged and
labeled) product to support the clinical development plan, as well
as the commercial sales plan as appropriate. Perform and/or
participate in internal audits, as assigned. Teamwork Participate
on cross-functional teams, as needed. Participate in special
projects as needed. Oversee Oversee quality aspects of
pharmaceutical development in an outsourcing environment, for DS,
DP and CTM, including the quality aspects of process and
formulation development, manufacturing, analytical testing,
packaging, labeling, product release, distribution and associated
stability programs, for assigned drug programs. Oversee supplier
quality management activities for assigned suppliers. Support
Support other objectives, as assigned. Provide back-up support to
other members of the Quality Assurance department as appropriate
and as needed. Compliance Oversight to include confirmation of
compliance, management of quality audits and inspection readiness
activities, and appropriate resolution of corrective and preventive
action plans, as required. Procedure Follow established procedures
for the oversight of quality aspects of pharmaceutical development
in an outsourcing environment, for drug substance (DS), drug
product (DP) and clinical trial material (CTM), including the
quality aspects of process and formulation development,
manufacturing, analytical testing, packaging, labeling product
release, and associated stability programs for assigned drug
programs. Requirements Education Bachelor's degree, preferably in a
science or related field. Experience 8+ years industry experience
in a leadership role. Demonstrated audit conduct and management
experience is desired. Knowledge Working knowledge of technical and
analytical aspects of pharmaceutical manufacturing. Working
knowledge of drug development process, FDA/EMA/ICH guidelines and
GMPs. Working knowledge of technical, analytical aspects, and
validation as applied to pharmaceutical manufacturing, testing and
equipment. Working knowledge of preparation and submission
activities, specifically in relation to CMC, for regulatory filings
in USA, EU and Rest of World. Skills Demonstrated project
management experience and skills, with the ability to coordinate
multiple projects in a demanding, fast-paced environment. Ability
to exercise judgment with minimal guidance in making decisions to
assure product quality and operational compliance. Demonstrated
ability to implement procedures which ensure compliance to GMP and
regulatory standards. Education Bachelor's degree, preferably in a
science or related field. Experience 8+ years industry experience
in a leadership role. Demonstrated audit conduct and management
experience is desired. Knowledge Working knowledge of technical and
analytical aspects of pharmaceutical manufacturing. Working
knowledge of drug development process, FDA/EMA/ICH guidelines and
GMPs. Working knowledge of technical, analytical aspects, and
validation as applied to pharmaceutical manufacturing, testing and
equipment. Working knowledge of preparation and submission
activities, specifically in relation to CMC, for regulatory filings
in USA, EU and Rest of World. Skills Demonstrated project
management experience and skills, with the ability to coordinate
multiple projects in a demanding, fast-paced environment. Ability
to exercise judgment with minimal guidance in making decisions to
assure product quality and operational compliance. Demonstrated
ability to implement procedures which ensure compliance to GMP and
regulatory standards. About UsFounded in 1998, Glaukos Corporation
is an ophthalmic medical technology and pharmaceutical company
focused on novel therapies for the treatment of glaucoma, corneal
disorders, and retinal diseases.Our company was the first company
to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the
micro-invasive procedure which revolutionized the treatment and
management of glaucoma. In 2012, we launched our first MIGS
device-the iStent --in the United States, followed by our
next-generation iStent -inject - -device in September 2018 and
iStent -inject - -W in September 2020.In November 2019, Glaukos
acquired Avedro, maker of the first and only FDA-approved
cross-linking technology for progressive keratoconus. And we
continue to seek to leverage our platform technologies to build a
comprehensive and proprietary portfolio of micro-scale surgical and
pharmaceutical therapies for glaucoma, corneal health, and retinal
diseases. Legal Disclaimer: Glaukos Corporation is an Equal
Opportunity/Affirmative Action Employer. view full text
Keywords: ViziRecruiter,LLC., Aliso Viejo , Manager Quality Assurance, GMP Pharma, Executive , Aliso Viejo, California
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