Sr. Quality Specialist I/II/III, Corporate Support (Pre-Clinical and Clinical QA)
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
Execution and support of Good Laboratory Practices (GLP); Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV), and Good Pharmacoepidemiology practices (GPP) quality programs; oversight of activities supporting Pre-clinical and Clinical Development, Medical Affairs, Pharmacovigilance and Regulatory for Purdue and all subsidiaries. All activities are conducted in compliance with federal regulations and company standards.
- Assure that pre-clinical, clinical and post marketing studies/programs are complete and meet internal and regulatory requirements:
- Participate on project teams as the quality unit representative to assure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
- Review project timeline to ensure it accurately captures all quality activities.
- In accordance with the project timeline, review and approve study plans and materials for compliance, and contracts/proposals to ensure they adequately capture QA requirements.
- Support continuous improvement and remediation for areas identified by internal audit and CI team initiatives.
- Serve as GLP/GCP/GPV/GPP subject matter expert in support of internal and external study teams.
- Develop/Manage a comprehensive annual audit plan including internal customers, vendors, and clinical sites consistent with industry standards.
- Support/Perform assigned audits and follow up. (This will require travel as appropriate).
- Provide management with documented status and metrics monthly.
- Ensure Quality Systems in client areas are effectively used to ensure compliance. Drive deviations/investigations to appropriate and timely resolution with CAPA.
- Perform QC and/or QA audits of documentation targeted for FDA and/or other key external parties. Work with client areas to maintain schedule of upcoming documents and agree appropriate review.
- Support regulatory inspections and post inspection follow-up and corrective action implementation.
- Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related clinical, safety and regulatory reporting.
- Performs other related assignments and duties as required and assigned.
Education and Experience
BS required and 6 years minimum relevant experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 4-6 years minimum relevant experience.
Necessary Knowledge, Skills, and Abilities
- Current working knowledge within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business including compliance systems and tools.
- Effective interpersonal, verbal and listening skills.
Knowledge of and adherence to appropriate regulations are critical.
Demonstrated application and working understanding, knowledge, and ability in primary discipline.
- Knowledge of GxP regulations in other disciplines and awareness of impact on cross-functional areas.
The Sr. Quality Specialist:
- Exercises good judgment in interpreting, understanding context and reporting data.
- Effectively identifies, describes, and communicates problem and impact in a timely manner.
- Routinely participates in problem resolution.
- Identifies, tracks, and resolves issues to closure.
- Proactively identifies potential problems and recommends possible solutions
Supervisory Responsibilities (if Applicable)
There are no direct reports for this role
This position is a Sr. Quality Specialist I,II, III level position. Minimum required education, experience, knowledge, skills and abilities are included in the posting. The position will be filled at the level commensurate with the successful candidate's education, experience, knowledge, skills, and abilities.
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Job Family Quality
- Pay Type Salary
- Travel Required Yes
- Travel % 10
- Required Education Bachelor’s Degree
- 201 Tresser Blvd, Stamford, CT 06901, USA