Assoc Dir, Quality Management (GCP)

Description

Associate Director, 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 responsibilitiesGeneral Profile•    Provides consultation on particularly complex aspects of ‘GXP’ to project teams and sponsors•    Drives the implementation of changes required to meet evolving regulatory requirements/industry developments•    Leads or contributes expertise to process-related initiatives•    Provides support to audits, inspections and Quality Issues, as assigned

Expertise•    Contributes expertise to designated initiatives•    Provides expertise to project teams for issue management•    Provides expertise for departments or geographies, as assigned•    Contributes to regulatory inspections and sponsor audits, as assigned

Complexity•    Contributes to or leads designated initiatives (may be complex) •    Directs others to resolve problems and/or conducts analyses (may be complex)•    Decision Making - Makes decisions that impact the organization/department/business.  Supports those that make daily operational decisions guided by policies, procedures, and business plans•    Influence - Builds and extends relationships with new and existing internal and external customers.  Influences staff and leadership on decisions that may have an impact on business direction.  Influences innovative thinking across departments•    Provides expertise to identify, prevent, and solve problems (may be complex)•    Drives solutions impacting the company•    Stays abreast of new regulatory and policy developments•    Accountable for the performance and direction of initiative teams where assigned as leader•    Responsible for resourcing and budget negotiation for initiatives where assigned as leader

Supervision•    Directs and controls the activities of initiative teams where assigned as leader•    May contribute to strategic planning from a quality or process perspective.•    May lead a team 

Other tasks•    Represents Corporate Quality and Syneos Health, as assigned•    Performs other quality-related activities as directed by CQ management•    Completes other Corporate Quality tasks, as assigned•    Travel may be required (approximately 25%)

Qualifications

What we’re looking for •    BA/BS degree in science or health care or equivalent education and experience, plus moderate experience in appropriate GXP(s).  •    Requires detailed knowledge of GxP/regulatory/technical/process.   •    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.