Principal Prof, Clinical Quality Management Specialist - Fully remote / urgent need

Description

Principal Professional, Quality Management

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

Job responsibilities
General Profile
• Provides quality support to consultancy for GCP and related topics (moderately complex) to project teams and departments, as assigned.
• Performs complex analyses to evaluate the state of the quality of a project team or department using key quality metrics and/or key performance indicators
• Investigates quality trends, potential risks and mitigations with Quality Management leadership
• Presents information to Quality Management leadership, as applicable

Functional and Technical Expertise
• Works within a specific knowledge area. May work outside area.
• Ensures commitments and timelines for assigned activities adhere to Syneos Health requirements.
• Offers solutions to process and quality related issues and identifies process improvement opportunities
• Advises Quality Assurance (QA) auditors and operational staff in providing procedural documents to sponsors, auditors, regulatory inspectors or other external parties.
• Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.

Complexity
• Solves complex problems and/or conducts complex analyses. Translates concepts into practice.
• Decision Making - Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
• Influence - Serves as a key resource within a business area or discipline. Gains support for ideas or positions on difficult issues
• Problem Solving - Anticipates and resolves complex problems. Applies strategic and critical thinking to identify solutions to non-standard requests and moderately complex problems
• Impact - Drives solutions for products, processes, and services across a large business area
• Customer/External Focus - Establishes key relationships with those outside of business area. Assesses and interprets customer’s (internal and external) quality needs and requirements and proactively develops solutions
• Project Management - Leads medium-scale, may lead large Quality Management projects or programs with moderate risks and resource

Supervision
• Normally receives little instruction on day-to-day work, general instructions on new assignments

Other tasks
• Represents Quality Management, as assigned
• Performs other quality-related activities as directed by management
• This position is not responsible for supervising employees

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Qualifications

What we’re looking for
• BA/BS degree in science or health care or equivalent education and experience, plus strong experience in Good Clinical Practice (GCP) in a Quality management role.
• Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), email and voicemail.
• Above average attention to detail and accuracy.
• Strong organizational, interpersonal and team-oriented skills.
• Ability to act independently and pro-actively.
• Significant project management and customer management skills.
• Ability to perform several tasks simultaneously to meet deadlines.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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