Job Summary & Responsibilities
IPM is seeking an industry-experienced, collaborative Quality Assurance (CMC) professional to implement strategy and promote effective operation of the quality system program at IPM. The QA Manager will be focused on performing Quality Assurance functions related to compliance with GXP regulations within IPM; outside of IPM by managing contract manufacturers; and external service providers.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:
Provide guidance and support to Product Development and Regulatory Affairs in compliance issues related to the production of all IPM Products
Lead and conduct audits of suppliers and contractors to ensure compliance with Global Company and Regulatory requirements.
Manage the follow-up of supplier audit reports and when necessary guarantee suitable corrective and preventive actions are in place. This also means effectively giving advice on agreement of actions and monitoring the effectiveness of those actions.
Compile and account on key performance indicators, compliance and metrics status of Internal Audits and GXP outsourced activities to Senior Management.
Contribute in the development of training programs for inspection readiness and improvements with Internal Audit and Supplier Quality Programs along with other Quality Systems.
Assist in Inspection Readiness activities and support Regulatory Inspections.
Interface and support project teams to certify that the goals set by the team as they relate to potential suppliers / contractors are consistent with quality objectives and appropriate governmental requirements. Review and approve all test methods, specifications, stability protocols and reports pertaining to IPM products.
Represent IPM QA at supply meetings and project team meetings with contract manufacturers.
Responsible for the review of production records and release of all IPM materials and products and associated documentation, including approval of labels, randomization codes, re-test date assignments and clinical packaging.
Establish and maintain complaint files.
Cultivate support and commitment across IPM departments in support of the QMS and facilitate development of controlled documents outside of QA.
Assure the execution of QA audit plans (including the GXP vendor qualification program and internal audits) and track the distribution of all QA audit reports and responses thereto.
Manage the change control system with IPM Product Development and for external service providers.
Participate in team meetings and review Product Development practices to assure compliance and quality.
Develop and maintain the required documents for compliance with applicable regulations (e.g., policies, SOPs, work instructions, quality agreements and design history files).
Support the Senior Director of QA in preparing for, facilitating and hosting regulatory inspections.
Support the Senior Director of QA in the preparation and presentation of periodic Management Reviews and development of key performance indicators to track the success of the QMS.
Coordinate the use of QA consultants to assure execution of QA audit plans, training and other QA activities as needed.
Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:
BA or BS Degree
Five (5)+ years of experience working QA/QC roles in a pharmaceutical manufacturing and/or medical device; experience with combination products and in GLP and/or GCP regulated environments would be preferred
One (1)+ of Supplier Quality and Internal Auditing experience in the pharmaceutical or medical device industry
Working knowledge of applicable global GCP, GMP, GDP and Quality Systems Regulations (QSR)
Knowledge, Skills, and Abilities
Excellent communication and interpersonal skills
Good organizational skill
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met.
Thorough knowledge of, and ability to interpret US and EU GMP regulations
Ability to work in a team environment
Up to 25% travel will be required
Terms and Conditions
Position will be based out of a home office or the Silver Spring office. Position may require national/international travel up to 25%. Job holder should expect fast-paced working environment. IPM is an Equal Employment Opportunity employer.
This job description should not be construed to imply that these requirements are the only standards for the position. Other duties will be assigned. IPM has the right to revise this job description at any time. IPM is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and IPM.