Regulatory Inspection Readiness

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jaqkz

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question. With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business. This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special. Inspection Readiness Supervisor About the role Describe the role briefly The purpose of the Quality Inspection Readiness Supervisor role is to support the site before, during, and after regulatory inspections from Regulatory Agencies, Internal Corporate and Third-Party audits and to ensure audit readiness at all times. This includes supplier and service provider auditing as well as the oversight and maintenance of the internal audit program at the site.
- Support the site Inspection Readiness program including coordination of internal and external audits and inspections.
- Manages site audit plan, including issuing audit reports and communication to managers; tracks audit commitments and manages monthly reporting.
- Prepare Inspection Readiness plans for regulatory agency inspections, corporate and customer audits.
- Responsible for supporting inspections at the site.




- Manages the internal audit program.
- Stays current with all relevant Federal, state, foreign, and corporate regulations, guidelines, and policies and industry trends.
- Supports regulatory queries from different markets.
- Establish a series of stretching, measurable improvement processes and metrics across the department which will be tracked to add value to both internal and external customers.
- Provide responsibility for other quality, product, and/or compliance activities as assigned. Key responsibilities: Demonstrate expert knowledge and ownership in key quality responsibilities below: - Hire, lead, develop and support Quality professionals to ensure the programs and processes are in place and aligned with regulatory agency and company requirements and expectations.
- Enhance the site inspection readiness program by: ensuring cross-functional inclusion of key SMEs are occurring to keep the site in ready inspection mode at all times; maintaining a frequently evaluated ‘top issues’ list of topics to be prepared to speak to during an inspection; ensuring frequent Gembas of the processes to understand the current state for any emerging top issues.
- Manage and Support regulatory inspections for the site; write and coordinate the issuance of a timely response to the Agency for any observations; and manage completion of commitments.




- Host Internal Corporate and Customer Audits; write and coordinate the issuance of a timely response for any observations, including follow-up reports. Manage internal commitments to ensure timely follow-up and completion as committed to the audit functions.
- Maintain Site Internal Audit and Self-Inspection programs.
- Communicate effectively and establish processes to ensure smooth communication within the department, across functions and across sites. Ensure two-way communications between Site Leadership and the department. Qualifications and skills Essential There is a range of educational experience allowed based on pharmaceutical experience obtained: - Bachelor’s degree in science or relevant field
- Minimum 3 years of experience in a regulated GMP industry Preferred
- Knowledge of cGMP’s/FDA and other Regulatory requirements such as ICH Guidelines 8, 9, 10, 11.
- Demonstrate initiative and analytical problem-solving skills - ability to use and interpret data to drive decision making at both tactical and strategic level.
- Requires project management and leadership skills.
- Ability to work well under high pressure and deadlines
- Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies.
- Excellent verbal and written communication skills required.
- Conflict resolution and interaction management skills required Contract: Fix Term - 1 year Please save a copy of the job description, as this may be helpful to refer to once the advert closes. Diversity, Equity and Inclusion At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fai

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jaqkz