Job Description

The Position Purpose

• Responsible for management of compliance activities in accordance with Roche policies, standards, procedures and Global cGMPs.
• Establish strategic goals and objectives and maintain full strategic responsibility for the Compliance organization
• Functional responsibilities include hosting and management of regulatory inspections and corporate GMP audits, management of the internal inspection readiness program, management of emerging regulations and systematic evaluation of new requirements, oversight for trending of Quality Compliance Performance, supplier management and Regulatory liaison.
• The Quality Compliance leader is the single point of contact at the site for external health authority queries and internal business partners.

Key Responsibilities Leadership and People Management:

• Create an environment of strong team spirit, timely and effective communication, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
• As a leader within the Quality Site Leadership team, drive network activities and alignment, cross-functional planning, and decision making.
• Accountable for overall budget and financial performance of the Compliance function.
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements.
• Embody PT lean principles and methods while fostering a continuous improvement mindset throughout the organization by encouraging experimentation and learning.

Technical and Functional:

• Provide strategic direction and manage execution of regulatory inspections, internal and external audits and paper-based inspections (e. g. moderation during inspections, providing daily summaries of inspection progress, support of timely preparation of responses to observations, ensuring logistical/infrastructure requirements)
• Provide strategic direction and oversight for the establishment and execution of the site self-inspection program. Ensure the program drives continuous improvement of the site\xe2\x80\x99s systems, processes and operational performance.
• Develop, lead, and execute inspection readiness activities for site
• Accountable for the response process and follow up on the mitigation activities, including coordination and interface with Global Functions and/or network sites as required.
• Manage the compliance risk program, including education of the site around new requirements, compliance trends
• Support Service Provider Management activities and interface with Global Supplier Quality team as defined by site.
• Establish, negotiate and maintain Quality Agreements in close collaboration with SMEs, Contract Management group and business partners Quality and Service Level Agreements.
• Liaison with PT Regulatory, lead coordination between site and PTR in close collaboration with site QA and site QS/QV.
• Supports Site Quality Head in terms of compliance questions, works together with other departments e.g. local manufacturing site, global functions like GQIM, External Relations
• Interface with Affiliates to maintain import licenses, support local Business Operations Functions to maintain and keep the necessary Wholesaler and Distribution Licenses if applicable

Safety:

• Comply with all RSTO\xe2\x80\x99s Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
• Implement, enforce and take ownership on all RSTO\xe2\x80\x99s Safety, Health & Environmental (SHE) requirements and initiatives within his/her areas of responsibilities.
• Ensure all employees are competent and provided with the necessary tools and equipment to work safely and without health risks.
• Observe all RSTO\xe2\x80\x99s site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately.

Lean Production System:

• Embody PT Lean Production System (LPS), while fostering and advocating a continuous improvement mindset and culture throughout the organization, by encouraging experimentation and learning.

Key Interfaces:

• Compliance, Regulatory, Health Authorities, All Site Functions

Qualifications (education/experience/knowledge/skills/competencies)

• Education:
  • Bachelor\xe2\x80\x99s Degree required (life science; biology or biochemistry is preferred); additional requirements may be specified by site and local needs.
  • Graduate or higher-level Degree is preferred

• Experience (may vary depending on site size/scope):
  • 10 or more years\xe2\x80\x99 work experience in the pharmaceutical or related industry
  • 6 or more years\xe2\x80\x99 people management experience
  • 4 or more years\xe2\x80\x99 quality, compliance or other relevant experience in the pharmaceutical industry

• Knowledge/Skills/Competencies
  • Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
  • Expert knowledge of cGMP relevant to the pharmaceutical industry; knowledge of the local and international GMP regulations
  • Expert knowledge with audit or inspection management
  • Possesses strong verbal and written communication skills and the ability to influence at all levels.
  • Builds trustful and effective relationships
  • Able to think strategically and translate strategies into actionable plans
  • Takes responsibility, drives results, and achieves expected outcomes

Who we are At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. Roche is an Equal Opportunity Employer.