Compliance Engineer (offline)
We are seeking an experienced Senior QA & Compliance Manager for our Biometrics division. This role is pivotal in ensuring the highest standards of quality and compliance within the organization. The successful candidate will be instrumental in supervising and enhancing our quality assurance programs, ensuring adherence to industry standards, and leading our efforts in audits, regulatory compliance, and project documentation.
Key Responsibilities:
• Quality Assurance Leadership: Oversee the quality of processes within the Biostatistics, Statistical Programming, and Data Management teams, ensuring projects are executed with the highest quality standards through best practices and innovative solutions.
• Compliance Management: Ensure full compliance with relevant industry standards, regulations, and guidelines (such as FDA, EMA, ICH-GCP), keeping abreast of regulatory changes and translating these into actionable policies and procedures.
• SOPs and Policies Supervision: Lead the development, implementation, and continuous improvement of Standard Operating Procedures (SOPs) and company policies, ensuring team adherence and training.
• Audit Leadership: Lead the company’s team in audit preparation, conduct, and follow-up, addressing findings promptly and improving processes and systems as needed.
• Project Documentation: Oversee the creation, maintenance, and review of comprehensive and compliant project documentation to support quality and regulatory requirements.
• Team Development and Leadership: Build, mentor, and lead a team of QA and compliance professionals, fostering a culture of continuous improvement, quality excellence, and compliance awareness.
• Collaboration with Key Departments: Work closely with the Biometrics, IT, and Project Management teams to ensure integrated quality and compliance efforts, serving as the key point of contact for QA and compliance matters both within the company and with external partners and regulators.
Required Skills:
•Bachelor’s or Master’s degree in a relevant field.
•Minimum of 5 years of experience in QA and compliance roles within the pharmaceutical, biotechnology, or related industry, focusing on biostatistics and statistical programming.
•Comprehensive knowledge of industry standards and regulations (FDA, EMA, ICH-GCP, etc.).
•Experience in developing, implementing, and leading SOPs and compliance programs.
•Proven leadership in conducting and managing audits with a history of successful regulatory inspections.
Strong leadership skills with an ability to mentor, motivate, and lead a team.
•Excellent communication, interpersonal, and organizational skills.
If you are passionate about quality assurance and compliance in the field of biostatistics and statistical programming and seek a challenging role in a dynamic environment, we encourage you to apply. Please submit your resume and a cover letter detailing your experience and why you are the ideal candidate for this position. Join us in our mission to improve health outcomes through high-quality biostatistical analysis, compliance excellence, and impeccable project documentation, in collaboration with key technology and management teams.
Key Responsibilities:
• Quality Assurance Leadership: Oversee the quality of processes within the Biostatistics, Statistical Programming, and Data Management teams, ensuring projects are executed with the highest quality standards through best practices and innovative solutions.
• Compliance Management: Ensure full compliance with relevant industry standards, regulations, and guidelines (such as FDA, EMA, ICH-GCP), keeping abreast of regulatory changes and translating these into actionable policies and procedures.
• SOPs and Policies Supervision: Lead the development, implementation, and continuous improvement of Standard Operating Procedures (SOPs) and company policies, ensuring team adherence and training.
• Audit Leadership: Lead the company’s team in audit preparation, conduct, and follow-up, addressing findings promptly and improving processes and systems as needed.
• Project Documentation: Oversee the creation, maintenance, and review of comprehensive and compliant project documentation to support quality and regulatory requirements.
• Team Development and Leadership: Build, mentor, and lead a team of QA and compliance professionals, fostering a culture of continuous improvement, quality excellence, and compliance awareness.
• Collaboration with Key Departments: Work closely with the Biometrics, IT, and Project Management teams to ensure integrated quality and compliance efforts, serving as the key point of contact for QA and compliance matters both within the company and with external partners and regulators.
Required Skills:
•Bachelor’s or Master’s degree in a relevant field.
•Minimum of 5 years of experience in QA and compliance roles within the pharmaceutical, biotechnology, or related industry, focusing on biostatistics and statistical programming.
•Comprehensive knowledge of industry standards and regulations (FDA, EMA, ICH-GCP, etc.).
•Experience in developing, implementing, and leading SOPs and compliance programs.
•Proven leadership in conducting and managing audits with a history of successful regulatory inspections.
Strong leadership skills with an ability to mentor, motivate, and lead a team.
•Excellent communication, interpersonal, and organizational skills.
If you are passionate about quality assurance and compliance in the field of biostatistics and statistical programming and seek a challenging role in a dynamic environment, we encourage you to apply. Please submit your resume and a cover letter detailing your experience and why you are the ideal candidate for this position. Join us in our mission to improve health outcomes through high-quality biostatistical analysis, compliance excellence, and impeccable project documentation, in collaboration with key technology and management teams.
About P-Product
Founded in 2006, P-product is an international US-based software development company proficient in Web, mobile, desktop & IoT development and support, as well as having extensive expertise in digital signal processors (DSPs), i.e. embedded development.Our Headquarters are located in Massachusetts while R’n’D centers are in Ukraine: in Kyiv and Kharkiv. We conduct our research and development projects in the Computer Vision, Machine Learning and Artificial Intelligence areas of expertise.
P-Product, Inc. is a growing software consulting company, having high-quality development standards, effective projects expertise and great working experience with customers.
We offer software & hardware development, technical support, IT-consulting, remote administration, and system integration services for various verticals & markets, providing our customers with the best solution for any complex task, creative problem solving and comfortable partnership models.
We have an effective and flexible methodology of works convenient for all our customers. Our Company has good records of accomplishing multi-domain projects for US, European, Asian, and Ukrainian partners.
We started our business from DSP — Digital Signal Processors. We like this word and we want to bring new meaning to the DSP term. We want to be your DSP — your Dedicated Service Provider.
Company website:
http://www.p-product.com/
DOU company page:
https://jobs.dou.ua/companies/p-product/
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