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1893 - Associate Director, Quality Management

Company: Certara Inc.
Location: New Haven
Posted on: May 5, 2021

Job Description:

Certara is hiring an Associate Director, Quality Management to join our Integrated Development Division (IDD)! This position can be based out of any East Coast Certara office, or full time remote.At Certara, we accelerate medicines to patients by partnering with life science innovators.In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:* informed decision-making & reduced clinical trial burden* higher R&D productivity* improved patient outcomes & increased patient access to medicines* accelerated regulatory approvalCertara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.Job Summary:The Associate Director, Quality Management (ADQM) is responsible for overseeing internal quality activities within Integrated Drug Development (IDD). The ADQM will function as a liaison with Certara Quality Assurance (QA) to ensure alignment and effective execution of quality management activities, thereby enhancing regulatory compliance, business growth, and limiting risk. The role will contribute to the functional excellence of IDD through process improvement and collaborating with key Certara stakeholders.Responsibilities:* Develop and maintain the IDD quality framework* Review and align IDD SOPs and other quality documents to new and existing service offerings* Ensure that internal QA are conducted and completed according to Certara QA requirements* Maximize the efficiency and success of client- and third-party-driven QA audits* Address audit findings and deviations together with functional IDD leadership* Align project execution with clients' quality expectations* Lead the internal QA training process in IDD* Assist in the validation and maintenance of software used within IDD* Actively contribute to best practices and continuous improvement* Manage client records/data retention policies and support individual client requests, as needed* Keep informed on regulatory, scientific and medical issues important to drug development, assigned products, and disease/therapeutic areasQualifications:* 5+ years in the quality management field with the life sciences industry* Graduate degree in medical/life sciences field (eg, bio-medical field)* Certification/accreditation in quality management* Experienced in the application of GLP/GCP regulations and guidelines in a regulated pharmaceutical setting* Strong understanding of the importance of SOPs/policies and of data integrity requirements* Knowledgeable of computer validation requirements in a regulated pharmaceutical environment* Experience in regulatory affairs or related functions in drug development preferred but not essentialSkills & Abilities:* Strong communication and interpersonal skills* Good group facilitation skills and ability to run efficient and effective meetings* Excellent computer skills: Microsoft Office* Highly respected team player.* Acknowledge multiple stakeholder requirements and work together to develop solutions* Comfortable working in a fast-paced, collaborative environment* Knowledge of the pharmaceutical industryCertara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.#LI-TE1Princeton, NJPhiladelphia, PANew Haven, CTRaleigh, NCCambridge, MAParsippany, NJNew York, New York

Keywords: Certara Inc., New Haven , 1893 - Associate Director, Quality Management, Executive , New Haven, Connecticut

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