Associate Director or Senior Manager of PV/GCP Quality Assurance - Europe

BeiGene Switzerland GmbH (Basel, Schweiz) Vor 9 Tagen veröffentlicht

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

NO AGENCIES

Mandatory experience - Pharmaceutical/Biotech/CRO industry ONLY

Ideally role will be based in Basel, Switzerland

General Description: 

The Senior Manager/Associate Director, GCP/GVP/GLP Quality is responsible for ensuring and fostering a pro-active, phase appropriate approach to GCP/GVP Quality Assurance. This position will be primarily responsible for ensuring research and development activities are conducted in accordance with applicable regulatory requirements, guidelines, laws and internally established standards and practices. For that the incumbent coordinates and conducts a variety of routine and complex GxP audits on assigned projects/products and provides independent assessments of the compliance of activities and processes with relevant regulations/guidelines (examples include but are not limited to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Laboratory Practices (GLP), ICH guidelines, local regulations and BeiGene SOPs/Working Instructions). This position identifies and assesses areas of risk; liaise with relevant compliance person in development to establish corrective and preventative actions as well as appropriate risk management plans.

Essential Functions of the job:

  • Support quality assurance (QA) activities related to EU, FDA and ROW regulations across therapeutic areas and provide guidance for all phases of drug development
  • Develop/improve and manage quality systems and processes to include:
  • Conducting/managing routine/for cause audit of investigator site, vendors, internal audits, etc.
  • Supporting the activities related to the vendor management process training, SOPs, etc.
  • Maintaining Key QA systems, such as investigations, Significant Quality Events (SQEs), Deviations, CAPAs, Audits
  • Developing and managing Integrated Quality Management Risk plans
  • Conducting/managing review of key documents such as study protocols, informed consent documents, Investigator brochures, Clinical study reports, submission modules, etc.
  • Defining quality metrics and measures to drive assessment and continuous improvement
  • Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
  • Coordinate and/or administer GCP/GVP training, as needed
  • Participate in the review of study related metrics (i.e. protocol deviation, etc.) as part of Quality Management Risk approach to identify gaps, trends and the need for process improvements
  • Manage inspection readiness activities and contribute to regulatory health authority inspections
  • Expert knowledge of GCP/GVP/GLP particularly EU, and ICH requirements
  • Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
  • Superb attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment
  • Exercise sound and balanced judgment in ensuring that written procedures are followed and in evaluating quality systems, processes, procedures, plans and protocols for compliance
  • Strong global knowledge and understanding of international regulations applicable to the conduct of clinical trials and pharmacovigilance operations
  • Other duties as assigned

Supervisory Responsibilities:  

This position may include managing staff: coaching and mentoring of junior staff at a later point in time with training/orientation/qualification and development plan for new Quality staff when required. Therefore, it is required to have strong leadership experience and mentoring skills. It also includes

management of contract auditors.

Computer Skills:  

  • PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)

Other Qualifications:  

Communication & Interpersonal Skills

  • Excellent verbal and written communication skills
  • Ability to effectively collaborate in a dynamic environment
  • Interacts with all levels of BeiGene

Travel: 

May require up to 20% travel

Education Required:  Bachelor’s degree, preferably in Science

Competencies:

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently.  Completes administrative tasks correctly and on time.  Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations.  Writes clearly and informatively.  Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed.  Contributes to building a positive team spirit; Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment.  Manages competing demands.  Changes approach or method to best fit the situation.  Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management - Communicates changes and progress; Completes projects on time and budget.

NO AGENCIES

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Associate Director or Senior Manager of PV/GCP Quality Assurance - Europe

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