Senior Quality Specialist II, GCP/PV/REMS Quality

Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications to meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians, and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications through internal research & development and strategic industry partnerships.

For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.

We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.

We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue's Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.

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 strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!

Job Summary

Responsible for the execution and support of quality programs and oversight of daily quality assurance activities supporting Clinical Research, Medical Affairs, and Pharmacovigilance activities, Regulatory submissions, and other regulated activities related to compliance with federal regulations and company standards for Stamford operations in Purdue Pharma L.P.

Principle Responsibilities

• Participate in the development and execution of a comprehensive annual Good Clinical Practices, Good Laboratory Practices, Pharmacovigilance, and Risk Evaluation and Mitigation Strategy ("GCP/GLP/PV/REMS") audit plan covering internal processes, vendor services and clinical site activities.
• Lead/manage the execution of defined audits utilizing internal/external resources in a cost efficient and effective manner. Ensure post-audit activities entail timely follow-up and resolutions.
• Serve as GCP/GLP/PV/REMS subject matter expert on teams. Assure that studies/programs are complete and meet internal standards and regulatory requirements:
• Ensure overall compliance, identify compliance gaps and ensure they are mitigated in a timely manner.
• Ensure project timeline accurately captures all quality activities.
• Review plans and materials for compliance, and contracts/proposals to ensure they adequately capture outsourced QA requirements.
• Lead continuous improvement and remediation for areas identified by audit/inspection and CI team initiatives.
• Collaborate with senior management and relevant stakeholders on corrective actions resulting from audits and regulatory inspections. Lead/manage efforts for verification of necessary completed corrective and preventative actions ensuring that compliance risks are satisfied.
• Internal Customers primarily include Drug Safety and Pharmacovigilance, Clinical Research and Development, Toxicology, Regulatory Affairs, Medical Affairs departments. Collaborate and support ad-hoc projects that enhance the overall compliance of the Company.
• Ensure pharmacovigilance activities including safety information processing and reporting follow regulations.
• Lead multiple key host roles for regulatory inspections and post inspection follow up and corrective action implementation.
• Lead / manage the quality support role for all post marketing studies, (including epidemiology, non-interventional studies, abuse deterrent studies) to ensure they are conducted in accordance with regulatory and company standards.
• Remain current on regulatory expectations and best practices through constant monitoring of changes to regulations, guidance documents, and industry trends related to clinical; safety and regulatory reporting.
• Perform other assigned responsibilities as required.

Education and Experience Requirements

Sr Quality Specialist II must have:

BS required and 8 years minimum experience, or equivalent level of experience in pharmaceutical or related industries; or graduate degree (MS preferred) with 6-10 plus years' experience or PhD with 3-6 plus years' experience.

Necessary Knowledge, Skills, and Abilities

The Sr. Quality Specialist II must demonstrate:

• Five years of Safety/GCP experience.
• Proficiency in understanding regulatory documents and the drug submission process.
• Proficiency in assessing data to ensure compliance with applicable GxP regulations and internal SOPs.
• Current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
• Effective interpersonal, verbal, and listening skills. Knowledge of and adherence to appropriate laws and regulations is critical. Proficient in MS Office software and applications
• The ability to anticipate challenges and drive full understanding of problems faced within the team.
• The ability to drive the analysis and change management process for how we solve problems and reach the goal.
• The ability to think broadly about the causes of problems, their impact, and their solutions.
• The ability to implement solutions and controls to prevent future problems and uses experience and awareness to identify problems early.

Physical and Environmental

• Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
• While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
• Ability to work a 10 hour per day/4-day work week, Monday - Friday; 40 hours per week with overtime as required.

Relocation is not offered for this position.

Purdue Pharma does not sponsor or facilitate any U.S. work or training authorization for this position. All applicants must have unrestricted and independent authorization to work or participate in an internship or training program at Purdue Pharma.

Minimum required education, experience, knowledge, skills, and abilities for Senior Quality Specialist II 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.

The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions. Additionally, the company may revise the job description at any time.

We are an Equal Opportunity Employer. Qualified applicants will receive consideration without regard to: actual or perceived race, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), national origin, ancestry, citizenship status, religion, color, age, creed, sexual orientation, marital status, gender identity or gender expression (including transgender status), protected medical condition as defined by applicable state or local law, genetic information, physical or mental disability, veteran status and military service, or any other characteristic protected by local, state, or federal laws and ordinance.

For more information about your rights under Equal Employment Opportunity, visit:

• EEOC Know Your Rights
• USERRA Rights
• Family and Medical Leave Act (FMLA)
• Employee Polygraph Protection Act (EPPA)
• E-Verify (English and Spanish)
• Right to Work (English and Spanish)

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The Company does not seek or accept unsolicited resumes or CVs from recruitment agencies. We are not responsible for any fees, commission, or any type of payment related to unsolicited resumes or CVs except as required in a written agreement between the Company and the recruitment agency or party requesting payment of a fee.

Under certain state law, we may be required to provide a reasonable estimate of the salary range for the jobs covered by this description. Actual salary determinations will take into account factors such as work location, prior education or training and experience, job related knowledge, and demonstrated skills aligned with the Company's internal leveling guidelines and benchmarks. Resumes may be considered in the order they are received.