Rd qa manager (España)

Rd qa manager (España)

04 ago
|
EyeD Pharma
|
España

04 ago

EyeD Pharma

España

Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.

EyeD Pharma headquarter is located in Liège

.
To support its development, EyeD Pharma is hiring an R&D; QA Manager. He or she provides leadership and direction for ensuring that development activities are conducted in accordance with relevant national and international standards and regulations to support EyeD’s projects and product registration. He or she must fully support and drive R&D; activities, communicate effectively with R&D; team members, multiple levels of management, and other support department

s.Your responsibiliti

es
In the Quality department at EyeD Pharma, the RD QA Manager w

- ill
Ensure the effective daily performance of the R&D; QA activities to meet goals and objecti
- ves.Promote Quality Culture by providing guidance, support, direction and leadership through positive interactions with all person
- nel.Ensure strong alignment and coordination with other departme
- nts.Provides oversight and guidance on quality compliance to all departments and project te
- ams.Oversee the business unit Quality Management Sys
- tem.Lead or support the development and/or revision of quality processes, procedures and risk assessment tools, ensuring proactive compliance and adherence to regulations and standa
- rds.Ensure that documentation supporting development programs and associated registrations are maintained in compliance with company standards and general regulati
- ons.Ensure that complaints, deviations, CAPAs, change controls are written, reviewed and managed correctly and on t




- ime.Make decision regarding quality issues and ensure appropriate communication and/or escalat
- ion.Utilize knowledge to improve R&D; operational efficiency. Work closely with others to identify opportunities for improvement and drive cha
- nge.Develop appropriate internal audits plan and ensure execut
- ion.Manage inspection/audit readiness activities for regulatory authority inspections and notified body audits. Participate in and provide direct guidance during external audits and inspecti
- ons.Communicate audit results to stakehold
- ers.Represent QA department in any assigned meet
- ing.Provide proactive quality assurance and risk assessment using FMEA and Quality by Design; and implement risk mitigation measu
- res.Plan and support suppliers’ audits, including clinical investigator site, CDMOs and CROs to determine compliance status and identify compliance ri
- sks.Participate in the evaluation and selection of suppliers and service providers and ensure appropriate agreements are in pl
- ace.Assume the role of PRRC for the Com
- panyAdhere to EyeD’s safety procedures and guideli

nes.
Your prof

- ile :Master of Sciences in Chemistry, Engineering, Pharmacy, Pharmaceutical and Biomedical Sciences or the like or equivalent by experi
- ence.Minimum 5 years in quality roles within a pharmaceutical and/or medical device environ
- ment.Minimum 2 years demonstrated experience in leadership




- role.Detailed knowledge of worldwide healthcare product quality compliance regulations (EMA and FDA as a minimum), guidance (including ICH) and standards (including ISO 13485 and ISO 14
- 971).Thorough knowledge of the requirements associated with the development of drug product, medical devices and/or a combination of
- both.Effective leadership skills, including the ability to provide constructive feedback respectfully to build positive relationships and improve business res
- ults.Strong organizational, planning, and follow-up skills and ability to hold others account
- able.Ability to multi-task and shift priorities quickly while working under tight deadl
- ines.Demonstrated ability to resolve quality and quality system-related issues in a timely and effective ma
- nner.Ability to work effectively alone or within a team, in a fast-paced changing environ
- ment.Excellent verbal and written communications with ability to effectively communicate at multiple levels in the organization, to foster support and to positively influence all stakehol
- ders.Proactive, risk-based approach with strong critical and tactical thinking sk
- ills.Mental agility to handle a large quantity and broad scope of information and activities while keeping making sound decis
- ions.Adhere to company’s values: team spirit, caring, integrity, efficiency, empower
- ment.Fluent in French and proficient in English at a professional level, both written and s
- pokenKnowledge of Veeva Vault is an
- assetPrior clinical trial and/or clinical evaluation experience is an a

sset.
EyeD Pharma

- offerA permanent position in an innovative and dynamic and fast-growing co
- mpany;Full
- time ;

Liège.
Please send your CV and cover letter in English to : job@eyedphar

ma.com.

📌 Rd qa manager (España)
🏢 EyeD Pharma
📍 España

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