A midsized pharmaceutical company is hiring Clinical Quality Assurance professionals! They are offering a competitive salary, merit based bonus. 401k matching as well as offer a pension/retirement savings account.  They offer 3 weeks’ vacation for employees at this level among other great benefits and health insurance.

Clinical Quality Assurance specialist

Raleigh, NC

A growing, midsized global biopharmaceutical company focusing on the discovery and development of medicines to combat diseases afflicting the immune system & central nervous system is hiring Clinical Quality Assurance specialists & auditors Full time!  If you are looking to work with a global company that offers competitive salaries, bonus, and other excellent benefits -  keep reading!

Description

- The CQA – Clinical Quality Assurance Specialist will partner with Global Projects and Development, Global Medical Affairs, Global Drug Safety and Pharmacovigilance and GMP Quality Operations in driving quality in the clinical activities across the global sites.

- To design and implement a robust clinical quality risk management program that profiles and mitigates risks associated with patient safety, data integrity and regulatory compliance.

- To provide direct compliance and investigative support to global company activities which are regulated by GCPs.

- This position will support operations related to global development of new drugs and/or new indications using GXP principles.

Qualifications

Minimum of 3-5 years work experience in Clinical QA auditing of clinical programs.  Good working knowledge of GxP principles relative to the development of pharmaceutical products.

Specific Skills:

- In-depth knowledge of worldwide regulations pertaining to GCPs for pharmaceutical products. 

- Knowledge and experience in auditing electronic systems and 21 CFR Part 11 computer system validation.

- Excellent writing, verbal, listening skills.  Strong presentation skills are necessary.

- Possess management and organization skills in an environment of rapidly changing priorities.

- Commitment to quality, integrity, and reliability.

- Excellent team player attitude and interpersonal relationship skills.

- Ability to travel nationally and internationally as business necessitates.  Travel could approach 50%.

- Analytical and creative problem solving skills

- ASQ certification or advance clinical degree

- Can apply compliance principles in complex situations.

- Analytical problem-solving attitude with practical working business partner knowledge.

- Additional language skills (eg Spanish, Portuguese, etc.) a plus

Core competencies:

Pharmaceutical quality assurance, GCP, good clinical practices, sponsor audits, clinical audits, CQA, Spanish, Portuguese, GxP compliance, FDA, MHRA, auditing electronic systems, computer system validation, GCPs for pharmaceutical products