Global QA/ra Manager

vor 2 Wochen

Basel, Schweiz Barrington James Vollzeit

Basel, Switzerland
- 14-06-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Quality Assurance, Regulatory Affairs
- SALARY TYPE
- Annually
- SALARY
- Negotiable

**Job Description: QA/RA Manager (Oncology Products)**

**Position Overview**:
We are seeking a highly skilled and experienced QA/RA Manager to join our pharmaceutical company based in Switzerland. As the QA/RA Manager, you will be responsible for ensuring the quality and regulatory compliance of our oncology products. This role is critical in maintaining the highest standards of quality and safety for our patients and ensuring compliance with applicable regulations and guidelines.

**Responsibilities**:
**Quality Assurance (QA)**:

- Develop and implement quality assurance strategies, policies, and procedures for oncology product manufacturing, testing, and distribution.
- Conduct internal audits to assess compliance with quality management systems, including Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other applicable regulations.
- Oversee and manage the batch release process, ensuring adherence to quality standards and timely product availability.
- Establish and maintain a robust document control system to manage quality documentation, including Standard Operating Procedures (SOPs), batch records, and quality agreements.
- Manage and investigate deviations, non-conformances, and CAPAs (Corrective and Preventive Actions) to identify root causes and implement effective corrective actions.

**Regulatory Affairs (RA)**:

- Develop and execute regulatory strategies for the successful registration and approval of oncology products in compliance with local and international regulations.
- Monitor changes in regulatory requirements and assess their impact on the organization's products and processes.
- Collaborate with cross-functional teams to ensure compliance with regulatory commitments and timely resolution of regulatory issues.
- Conduct regulatory intelligence activities to stay updated on evolving regulations and guidelines related to oncology products.

**Compliance and Audits**:

- Lead and coordinate external regulatory inspections, customer audits, and third-party inspections, ensuring preparedness and timely responses.
- Implement and maintain a comprehensive compliance program, including training, to ensure employees are aware of relevant quality and regulatory requirements.
- Identify compliance risks and proactively develop strategies to mitigate them.
- Collaborate with cross-functional teams to ensure the timely implementation of corrective and preventive actions resulting from audits and inspections.

**Cross-functional Collaboration**:

- Collaborate closely with cross-functional teams, including Manufacturing, R&D, Clinical, and Commercial, to ensure alignment on quality and regulatory requirements.
- Provide guidance and support to stakeholders on quality and regulatory matters, ensuring awareness and adherence to applicable standards and guidelines.
- Participate in cross-functional meetings and provide expert input on quality and regulatory topics.

**Qualifications and Experience**:

- Bachelor's degree or higher in a scientific discipline or related field. Advanced degree preferred.
- Minimum of X years of experience in quality assurance and regulatory affairs within the pharmaceutical industry, preferably in the field of oncology products.
- Strong knowledge of international regulatory requirements and guidelines, including but not limited to FDA, EMA, and ICH guidelines.
- Proven experience in managing regulatory submissions, inspections, and audits.
- In-depth understanding of quality management systems, GMP, GLP, and other relevant quality standards.
- Excellent communication and interpersonal skills with the ability to collaborate effectively with cross-functional teams.
- Strong problem-solving and analytical skills with a keen attention to detail.
- Ability to work in a fast-paced and dynamic environment, managing multiple priorities simultaneously.
- Fluency in English (both written and spoken) is required. Knowledge of additional languages is a plus.

If you are passionate about ensuring the highest standards of quality and regulatory compliance for oncology products and have the required expertise, we invite you to join our dedicated team.

Consultant
- Tomas Swithenbank
- +441293776644

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