Sr Mgr, QA & Reg Compliance- Northeast USA

Description

Senior Manager, QA & Regulatory Compliance

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

* Maintain current knowledge of Clinical systems as of therapeutic areas, SOPs, relevant legislation and ICH GCP guidelines; provide guidance and act as Subject Matter Expert respectively.

* Identify risks and non-compliances, propose, and negotiate solutions, support CAPA creation, review and drive implementation. Track progress to achieve results. Escalate issues accordingly, if required.

* Employs strategic thinking and problem-solving skills to propose and implement solutions to complex issues.

* Independently, identify trends, perform root-cause-analysis (if necessary), and develop action plans accordingly.

* Provide input and execute the quality plan by analysing quality metrics and identifying trends and areas of improvement. Develop and deliver training accordingly to achieve compliance in trial conduct.

* Able to streamline processes and drive process optimization without compromising quality, develop and leverage new tools to enhance agility and efficiency.

* Perform on-site quality visits and checks to verify the quality status and provide feedback.

* Independently, develop local quality plan, analyse results, provide and follow up on the action plan.

* Assist in the tracking of planned and scheduled audits and inspections in the respective systems.

* Assist in the documentation, preparation, conduct and follow-up of audits and inspections, including training and compliance.

* Develop appropriate tools and templates for managing audits and inspections.

* Support the Clinical Quality & Training as well as the Clinical Operation team by maintaining, filing and archiving appropriate and consistent Quality Assurance documentation, including training records.

* Build and maintain strong working relationship with internal and external stakeholders, including a close collaboration with various local, regional and global stakeholders to understand the future process requirements.

* Create and drive a culture of critical thinking and risk-based quality management.

* May mentor and train Manager, Quality and Regulatory Compliance

* Perform other work-related duties as assigned.

* Minimal travel may be required (up to 25%).

Qualifications

* Computer literacy commensurate with job requirements (Microsoft Office suite; basic SharePoint

proficiency).

* Excellent knowledge of industry standards and regulations related to clinical trial quality management, incl. GCP guidelines.

* Strong experience in Clinical Operations processes and clinical trial conduct.

* Able to handle multiple tasks to meet timelines in a dynamic environment.

* Experience of participating in cross-functional teams of business professionals. Demonstrated leading / participating in such teams.

* Able to conduct and facilitate difficult conversations.

* Experienced in quality management / compliance (e.g. audit/inspection support incl. CAPA management, SOP management, compliance issue management, training, etc.)

* Analytical and risk-based mindset.

* Proactive attitude.

* Strong organizational, presentation and interpersonal skills.

* Strategic mindset with proven decision-making and problem-solving capabilities in difficult situations.

* Cultural sensitivity to allow effective communication with stakeholders from diverse cultural backgrounds.

* Well-developed communication skills and the ability to write necessary documentation (e.g. tools).

* Minimum of 6 years of relevant operations/clinical trial monitoring & execution in pharmaceutical industry or Clinical Research Organization.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges from $79,800 to $139,600. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.