PPD Sr PV Quality and Compliance Specialist - German speaking , EMEA - 3,000 EUR joining bonus in Slovakia
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Serves as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Interprets data on complex issues, leads teams and makes good business decisions with support. Oversight of quality and hub locations, will be responsible for activities such as KPI management remaining compliant with company and regulatory policies and procedures.
Essential Functions and Other Job Information:
- Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements.
- Develops varied support materials, presentations, and/or tools to support department's remit and strategies.
- Proactively collaborates with initiative leads and management to develop, optimize and improve processes, associated systems/applications, training and communications.
- Leads small to medium-scale process improvement initiatives.
- Develops process improvement processes and solutions.
- Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs.
- May review, assess and update procedural documents for overall compliance with current processes.
- Performs special projects, assignments and administrative tasks per business needs.
- Provides training and guidance to junior team members.
KPIs will include:
- Training Compliance o Employee and departmental completion of training.
- Procedural Compliance o Rollout of procedures (implemented on time, overdue etc.)
- Quality Event Management o On time closure of CAPAs that originated from procedural deviations, audits or inspections.
- Regulatory submissions
Education and Experience:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).
- Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
Knowledge, Skills and Abilities:
- Thorough understanding of procedural documents
- Strong understanding of process improvement fundamentals
- Solid investigative and analytical skills
- Strong negotiation skills
- Thorough understanding of clinical management technology and systems, and strong computer skills
- Effective judgment, decision making, escalation, and risk management skills
- Effective oral and written communication skills including the ability to communicate in English, both orally and in writing
- Strong interpersonal skills and problem solving ability
- Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting
- Strong attention to detail
- Thorough understanding of regulatory guidelines and directives
- Strong creative and critical thinking skills
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.
Job: *Clinical Management
Organization: *DE BU
Title: Sr PV Quality and Compliance Specialist - German speaking , EMEA - 3,000 EUR joining bonus
Requisition ID: 190987
Other Locations: Belgium, Romania, Portugal, Bulgaria, Spain, Slovakia, RS-Serbia, United Kingdom, Croatia, CZ-CZ-Prague, Ukraine, Hungary, Italy, Serbia, Poland, Greece
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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