Associate Director GMP Operational Quality Assurance Medical Device Hybrid
Associate Director GMP Operational Quality Assurance Medical Device Hybrid
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$ 154100 - 231200
1 Vacancy
Job Description
Job Description
General Summary
The GMP Operational Associate Director is recognized as an expert internally in the principles and application of quality assurance and compliance. The GMP Operational Associate Director will provide QA support of manufacturing operations oversee sterilization processes and microbiological testing and serve as a Product Quality Lead for the activities supporting Medical Devices.
The GMP Operational Associate Director should excel in an environment that embraces teamwork change riskbased decision making and flexibility. This individual should be willing to make a significant contribution to a multidisciplinary team must be selfmotivated to take action and have excellent written and verbal communication skills. The qualified candidate will act provide quality assurance support quality systems and compliance activities working crossfunctionally with R&D Product/Process Development Manufacturing Supply Chain QC and QA.
This individual will have a strong background experience and/or understanding in Design Controls Risk Management Quality Systems GMP Manufacturing and Combination Medical Devices.
***This is a hybrid role based in either Boston MA or Providence RI***
Key Duties and Responsibilities:
- Provides quality assurance support in design and development activities of combination medical device products and facilitates the application of design controls and risk management. Supports Design History File establishment creation approval and maintenance.
- Reviews and approves design documentation including but not limited to verification and validation methods test plans protocols and reports test and inspection documents design engineering drawings statistical analysis methods and risk documents (design and process).
- Develop implement and maintain quality management systems for sterilization processes and microbiological testing in accordance with regulatory requirements (e.g. FDA and ISO).
- Collaborate and provide guidance and support in areas such as sterilization validation microbiological testing methodologies and data analysis.
- Oversee microbiological testing procedures both internally and externally at Contract Testing Laboratories.
- Conduct riskassessments and implement corrective and preventive actions (CAPAs) to address any deviation or nonconformities identified during sterilization or microbiological testing processes.
- Stay abreast of industry trends regulatory updates and emerging technologies related to sterilization and microbiology and incorporate relevant changes into quality management systems.
- Serve as a subject matter expert on sterilization and microbiology testing matters providing guidance and support to internal stakeholders and external partners as needed.
- Provides leadership in all areas of the Quality System including but not limited to Root Cause Analysis CAPA Nonconforming Material Investigations and Reporting Deviations Change Control Supplier Qualifications and Audit support functions (internal and external).
- Perform appropriate duties as assigned by management.
Required Education Level and Experience:
- Seven 7 years of relevant industry experience such as manufacturing quality assurance and/or quality control in cGMP related industry with four 4 or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities.
- Preferred Masters degree or relevant comparable background.
Required Experience Knowledge/Skills
- Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e. process air water for injection etc.
- Knowledge of standard microbiological procedures (sterility testing environmental monitoring bioburden and bacterial endotoxin testing)
- Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e. process air water for injection etc.
- Knowledge of standard microbiological procedures (sterility testing environmental monitoring bioburden and bacterial endotoxin testing)
- Must have experience in ethylene oxide steam sterilization and gamma radiation requirements.
- Knowledge of FDA cGMP ISO 146441 standards ISO 11135 and other sterilization related documents
- Able to work in a fastpaced environment and meet quality accuracy and timeliness objectives.
- Able to integrate activities with other groups departments and project teams as needed.
- Demonstrated experience providing QA support and oversight of GMP manufacturing operation.
- Experience successfully leading event investigations Root Cause Analysis and CAPA
- Experience with networkbased applications such as Oracle Veeva
- Understanding of regulatory environment including quality systems and compliance.
- Knowledge of ISO 13485 ISO 14971 and combination product standards is an advantage.
- Demonstrated ability to support evaluation of quality matters and solve straightforward problems using technical experience judgement and a riskbased approach.
- Professional membership or equivalent in relevant societies network of knowledge in cell and gene therapy industry.
- Ability to evaluate quality matters and make decisions utilizing riskbased approach.
- Must have strong technical writing skills.
- Strong written and verbal communication skills are required as is the ability to effectively communicate with crossfunctional teams.
Were enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or OnSiteEligible role you canchoose to work:
1.Hybridand work remotely up to two days per week;or select
2.OnSite andwork 5 days per week with ad hoc flexibility.
#LIAR1 #LIHybrid
Pay Range:
$154100 $231200Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other jobrelated factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive marketleading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a weeklong company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
HybridEligible Or OnSite EligibleFlex Eligibility Status:
In this HybridEligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. OnSite: work five days per week onsite with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an EVerify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Director
Employment Type
Full-Time
