Auftragsdetails

This Senior Consultant, Compliance (Medical Device and Diagnostics) is responsible for independently managing compliance-related projects and providing consulting and contract services for quality-related issues, as needed. This position will be a subject matter lead for assigned areas and compliance projects within the ProPharma Group.

Essential Functions Include:

• Subject matter lead for specific quality assurance and regulatory compliance projects within the company.
• Understand and provides oversite for compliance and quality systems activities within the medical device and diagnostics areas.
• Participate in client calls and work with Business Development to fully understand client needs and build proposals based on those needs.
• Provide support to clients and all functional units of ProPharma Group as quality and regulatory compliance issues such as deviations and non-conformances arise.
• Evaluates and authors documents aligned in the design control process related to the development and lifecycle of devices and diagnostics.
• Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
• Ensure compliance of company operations to quality principles in the development of internal quality systems through SOP writing and training.
• Provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.
• Ensure the Compliance and Quality Assurance practice is compliant with all applicable internal and external policies procedures and industry best practices.
• Promote continual improvement regarding customer satisfaction with an emphasis on quality and compliance services.
• Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.
• Audit projects for correct approach, consistency, and quality.
• Utilize expertise of design control and quality systems to conduct audits and provide gap analyses and risk assessments for clients.
• Perform customer service functions in response to client inquiries.
• Assist with interviews of ProPharma Group candidates.
• Other duties as assigned.

Qualified candidates must have:

• Required: BS/BA in a scientific discipline.
• Preferred: Graduate degree in a scientific discipline.
• 10 years in the quality/compliance area in healthcare.
• 5 years in the device and/or diagnostics areas.
• Quality orientation and high attention to detail.
• Demonstrated ability to lead people and get results through others.
• Strong working knowledge of medical device and diagnostic regulations, standards, guidelines.
• Knowledgeable in compliant handling, NCRs and CAPA as they relate to the overall quality management system and compliance.
• Ability to interact in a professional and positive manner with clients and co-workers.
• Strong editorial skills for the review and approval of quality documentation, including protocols, reports, SOPs, design history files, etc.
• Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
• Ability to manage and work with multiple individuals (where applicable); in company quality program and compliance-related activities.
• Ability to manage and execute multiple tasks associated within the compliance, quality assurance, and validation fields.
• Exceptional communicator with strong persuasion skills and presentations.
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record with team leadership, problem-solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.
• Experience creating and working with high-performance teams.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• Ability to think ahead and prepare action plans to achieve results.
• Strong “soft” skills with the ability to engage with different groups internally and externally, building strong relationships and leveraging those relationships in a positive way to drive results.
• Ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Excellent analytical skills and the ability to access and resolve difficult business situations.
• Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment.
• Some travel is required based on client engagements and expectations for on-site meetings.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***