Senior Specialist, Quality Assurance

Job Description

Position Overview

The Senior Specialist, Clinical Supplies Quality, Global Development Quality is responsible for support of the Clinical Supply Chain for clinical development programs for our company's portfolio, specifically in terms of assuring the reliable availability, quality and regulatory compliance of clinical supplies produced. This position will have responsibility for support of US quality operations and disposition, global distribution planning and management, and acquisition integration.

Primary Activities

This position will require an in-depth close collaboration with the key stakeholder groups including Global Clinical Supplies, Global Development Quality, Regulatory Affairs, Device Development & Technology, and External Development & Manufacturing, and Global Clinical Trial Operations as well as multiple functions within the clinical supply chain. This position will also include navigating dynamic, high impact, and high visibility situations on a regular basis in relation to ensuring that our company's clinical development portfolio/pipeline is not disrupted due to issues with clinical supplies.

In addition to the high-level responsibilities discussed above, the incumbent is expected to independently execute on the following:

• Provision of in-depth technical and quality expertise regarding clinical supply operations and integration, Medical Device/Combination Products, and new technologies.

• Development and execution of Quality and key stakeholder strategies, improvement initiatives in line with business drivers and objectives whilst streamlining processes and procedures and leveraging technology.

• Evaluation and disposition of Clinical Supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations.

• Coordination and/or support the investigation of deviations and significant quality events.

• Identification of trends and/or potential compliance gaps and proactively leading the resolution of significant issues affecting quality and ensuring reliable clinical supply chain.

Required Skills:

Primary skills include but are not limited to:

• Strong technical expertise in R&D activities specifically related to clinical supplies; experience in Medical Device/Combination Products and New Technologies is preferred

• Strong compliance knowledge and understanding of regulatory agency regulations and requirements including proficiency in interpreting and applying cGMPs to R&D environment

• Demonstrated experience working with external parties and stakeholders; ability to interact with and influence stakeholder subject matter experts and senior leaders

• Demonstrated knowledge of continuous improvement methodologies; ability to manage complex cross-functional initiatives

• Demonstrated leadership, including strategy development / deployment and experience with tangible delivered benefits.

Required Education/Experience:

• Bachelor’s Degree in Scientific Discipline with 5+ years relevant experience within the pharmaceutical industry or Good Manufacturing Practice (GMP) related field (including Technical, Engineering, Quality or Operations) or advanced Degree with 6+ years relevant experience.

• Familiarity with batch disposition (release) activities.

• Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs).

• In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.

• Demonstrated teamwork skills.

• ·Attention to detail, flexibility and awareness of production and quality control problems.

Preferred Skills:

• Ability to independently manage multiple priorities and projects.
• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
• Demonstrated analytical and problem-solving skills.
• Knowledge of Lean Six Sigma and Project Management.
• Knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.

#EligibleforERP

Required Skills:

CAPA Management, Detail-Oriented, Deviation Management, Medical Devices, Process Improvements, Quality Risk Management, Six Sigma, Teamwork

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual…