Sr Professional Quality Management

3223 Syneos Health Germany GmbH Sede Secondaria; Hyderabad; Hybrid; INR 1,500,000 - 2,100,000; Full time

Job summary

Syneos Health is seeking a Quality Assurance professional to support Clinical Monitoring teams during sponsor site audits and assist in preparing training documentation and TMF materials. You will work on audits, inspections, and corrective actions to ensure compliance with GXP, GMP, and related standards.

The role requires strong project management, attention to detail, and the ability to work cross-functionally in a fast-paced environment. Travel ~15% may be required.

Qualifications

• BA/BS in science or health or equivalent education and experience with GCP/GLP/GMP preferred.
• Proficiency in Word, Excel and PowerPoint, email and voicemail.
• Strong organizational, interpersonal and team-oriented skills.
• Independent and proactive work style with significant project management experience.

Responsibilities

• Supports CM teams during sponsor site audits and site preparations.
• Performs quality checks on training documentation and TMF/study documents.
• Assists during Audits and Inspections; conducts root cause analysis and CAPA actions.
• Provides quality management consultancy to operations and ensures adherence to timelines.
• Represents Quality Management as assigned; travel up to ~15%.

Skills

Attention to detail

Quality management

Project management

GCP/GLP/GMP knowledge

Analytical thinking

Education

BA/BS in science or health

Tools

Microsoft Office

TMF documentation tools

Job description

Discover what your 25,000 future colleagues already know:

• 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 building an inclusive culture – where you can authentically be yourself.
• Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with.

Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Job Summary Performs various activities (analysis, investigation, reporting, administration) related to ‘GXP’ (e.g. Good Clinical Practice or Good Pharmacovigilance Practice) and related topics for Clinical departments (therapeutic areas and functions).

Core Responsibilities

• Supports Clinical Monitoring (CM) teams through the duration of sponsor site audits
• Work with CM teams for the preparation of site audits, which includes performing quality checks on training documentation/TMF/study documents.
• Assist and work with CM teams during Audits and Inspections to determine underlying Issues, perform Root Cause Analysis (RCA), formulate appropriate Corrective and Preventative Actions (CAPAs), and implementing Effectiveness Checks.
• Provides quality support and consultancy for Quality Management and Operations, as applicable
• 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.
• Solves moderately complex problems and/or conducts analyses. Translates concepts into practice.
• Makes decisions that impact a range of standard and non-standard operational, process, project or service activities
• Serves as a key resource within a business area or discipline.
• Anticipates and resolves problems, which may be moderately complex. Applies critical thinking to identify solutions to requests and problems
• Drives solutions for products, processes, and services
• Leads medium-scale Quality Management projects or programs with moderate risks and resource
• Normally receives little instruction on day-to-day work, general instructions on new assignments
• Represents Quality Management, as assigned
• Performs other quality-related activities as directed by management
• This position is not responsible for supervising employees
• Reviews controlled documents, providing input on content alignment with Syneos Health controlled document standards and (where appropriate) technical content.
• Travel may be required (approximately 15%)

Qualifications Education Requirements Min/Preferred Education Level Description

• BA/BS degree in science or health care or equivalent education and experience, plus some experience in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) preferred.
• 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. http://www.syneoshealth.com

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.

Workplace culture

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.

The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Our Guarantees

• Partner with the most diverse team of experts in the industry.
• From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it.
• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment.
• We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.