Thermo Fisher Scientific Sr/Compliance Manager (QA, Real World Data), Some EMEA locations in Czestochowie, Poland
We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health (https://www.ppdi.com/about/purpose-mission-strategy) . You will be joining a truly collaborative and winning culture (https://www.ppdi.com/careers/about/culture) as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.
As a Senior Compliance Manager for Real World Data Solutions (RWDS), you will revamp a Quality System to include Real World Evidence guidance and direction, encompass and measure data quality and data integrity and customer satisfaction in the real world data and real world evidence space, and oversee the quality function of the RWDS group to include managing quality events, planned deviations, procedural documents and external audits.
Provides strategic direction and management of a real world data specific quality management system program. Where and when role requires, incumbent provides oversight to auditing techniques, quality management training, interpretation of regulations and guidelines, technology best practice as well as computer validation and compliance. Assists business development and senior management in securing new business via request for proposal support. Develops and supports effective solutions, using proven problem solving techniques, to address nonconformance issues with existing clients. This will include responsibilities in supporting quality systems and investigations or deviations and the corrective and preventive (CAPA) action plans. Participates in training activities which will include generating training and delivery.
Develops and executes RWDS quality planning, assurance, control, record retention, corrective and preventive action process and process improvement initiatives ensuring these quality assurance and quality control measures are in line with and comply with the existing applicable CRG processes and procedures
Assists with the creation, maintenance and compliance with procedural documents (e.g., standard operating procedures (SOPS), job aids, etc.)
Identifies and collaborates with peers in QA and within RWDS to proactively identify issues impacting quality, determines root cause of nonconformance, and develops effective problem solution strategies
Analyzes compliance/quality matrix data and notifies senior management of critical compliance nonconformance
Leads process/quality improvement initiatives and serves as project lead for department quality initiatives
Provide support for client audits
Leads quality and compliance processes and engages with a variety of cross-departmental staff to ensure appropriate execution and completion (e.g., quality events, planned deviations, inspections and audits, procedural documents, vendor oversight)
Develops and effectively shares guidance and reference information, repositories, and communication channels (e.g., requests for information/ proposals (RFI/RFP), policies, procedures, guidance documents, quality management systems training)
Assists in business development activities to obtain additional contracts by providing input to the proposal process and making presentations to potential clients
Develops tools and other materials for tracking of compliance management activities and analyzes trends
Creates formal networks with key contacts across the department
Assesses impact of client and regulatory observations on data integrity and/or quality management and provides recommendation for corrective action to the respective teams. Reviews and approves deviations and corrective actions and preventive actions (CAPAs)
Develops and maintains applicable quality and site metrics. Participates on quality and business process improvement issues
Handles delegated tasks and responsibility as requested by senior leadership. Represents RWDS QA at client audits and regulatory authority inspections.
Maintains expertise with RWD-RWE regulatory requirements by attending external training programs, maintaining current reference library and attending FDA sponsored public conferences.
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 8+ years).
Must have 2 years of the 8 years QA experience in a pharmaceutical or hospital data setting
Knowledge, Skills and Abilities:
Experience in technology implementation and change management
Experience developing processes to support the development and evolution of product, including designing systems for collecting customer feedback and tracking and acting on market trends.
Experience collaborating with architects, marketing, engineers and bio informatics, to create product concepts plan implementation, natural language processing (NLP) and carry out delivery.
Extensive knowledge of the clinical trial process. Experience in peri-&post approval and outcomes research is a plus
Comprehensive understanding of RWE-RWD guidelines and other relevant regulations and guidelines
Effective negotiation and problem solving skills
Proven oral and written communication skills
Strong influencing and motivational skills
Demonstrated organizational and time management skills
Proven examples of collaboration cross-functionally to manage or improve quality management system activities
Strong writing and computer skills; ability to learn and become proficient with appropriate software
Ability to multitask and prioritize competing demands/workload
Proven flexibility and adaptability
Audit experience (e.g., internal audit execution) and program management a plus.
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize 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 clinical research services you will benefit from an award-winning learning and development programme (https://www.ppdi.com/careers/about#Training) , 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 (https://www.ppdi.com/careers/life-at-ppd) , where PPD clinical research services 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 organization but with a local feel.
Our 4i Values:
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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