The purpose of the role is to provide independent corporate oversight of significant Quality and Regulatory Compliance risks across the organization. This includes effective risk escalation and management, recall governance, audit oversight, and nitrosamine management, ensuring that significant risks are appropriately identified, assessed, mitigated, and communicated to senior management.

KEY ACCOUNTABILITIES

Quality Compliance & Regulatory Oversight

·       Provide corporate oversight of pharmaceutical quality compliance requirements and emerging regulatory expectations.

·       Monitor significant compliance risks and trends across the organization and ensure appropriate escalation to senior Quality leadership.

·       Provide independent advice on significant compliance matters and their potential regulatory, product quality and patient impact.

Quality Risk Management

·       Provide governance and oversight of the corporate Quality Risk Management framework.

·       Ensure significant Quality Risks are appropriately identified, assessed, mitigated, monitored and escalated.

·       Oversee the consolidation and tracking of significant Quality Risks across operational units, including through Quality Forward.

·       Identify emerging and recurring risk trends and ensure appropriate management attention and action.

Escalation, Alerts & Recall Management

·       Establish and maintain effective mechanisms for escalation and management of significant Quality and Compliance alerts.

·       Ensure timely assessment and escalation of significant quality events with potential impact on patients, product quality, regulatory compliance or supply.

·       Provide Quality governance and oversight for product recalls and other significant market actions.

·       Ensure appropriate cross-functional decision-making, regulatory engagement and follow-up for significant events.

Audit & Inspection Oversight

·       Establish and oversee the corporate, risk-based Quality audit strategy and annual audit plan.

·       Consolidate audit requirements across Development, Manufacturing, sites and affiliates and ensure effective allocation of internal and external audit resources.

·       Oversee significant audit findings, trends and recurring observations and ensure appropriate escalation and follow-up.

·       Provide oversight and support for regulatory inspection readiness and response for significant or corporate-level inspections.

Nitrosamine Management

·       Provide corporate governance and oversight of the organization's nitrosamine risk management strategy.

·       Ensure appropriate identification, assessment, testing, mitigation and monitoring of nitrosamine risks across the product portfolio.

·       Oversee significant nitrosamine-related risks, regulatory commitments and escalation to senior management.

·       Ensure appropriate cross-functional coordination between Quality, Regulatory Affairs, Development, Manufacturing and other relevant functions.

REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS

·       University degree in Pharmacy, Chemistry, Biology or relevant Life Science is an advantage.

·       Minimum of 15 years in similar role in pharmaceutical company

·       Production experience is essential, together with experience leading audit teams.

·       Strong technical expertise in Quality & Compliance, including regulatory inspections and interactions with health authorities.

·       Advanced knowledge of English

·       Extensive experience in pharmaceutical quality compliance, with a track record of successful leadership in global roles.

·       In-depth knowledge of international standards (e.g., ICH, ISO) and regulatory requirements.

·       Proven leadership skills, including the ability to drive change and foster a culture of quality excellence.

·       Experience in transformation, working in dynamic environment

·       Skilled in Communication (impactful, assertive and persuasive) 

·       Flexibility and ability to manage competing priorities

·       Sense of urgency, high autonomy & stress resistance, agile personality

·       Proven hands-on attitude, be flexible and adaptable, open minded

·       Possess strong change management, negotiation and influencing skills

·       Open minded, positive and energetic person

Diversity is a fact. Inclusion is an act @Zentiva  
 
At Zentiva, we are a team of 5000 unique talents bonded together by our purpose to provide health and well-being for all generations. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnical backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. 

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