Quality Manager for Compliance & GDP Processes (m/f/d)
YOUR TASKS AND RESPONSIBILITIES:
This position offers an exciting opportunity for you as a senior quality professional to oversee and advance the Quality Management System (QMS) for BCC AG (Consumer Health). As the Senior Quality Manager BCC for Compliance & GDP Processes, you will ensure that all processes, procedures, and documentation meet Quality regulations, with a particular focus on GDP oversight for BCC AG. Operating within the environment of the Divisional Headquarter of Bayer Consumer Health, your role is essential to ensure compliance with Swiss regulations, collaborating with product supply, creating value opportunities, supporting business, and upholding the GDP quality standards.
KEY TASKS:
- Manage and maintain the Quality Management System (QMS) for BCC AG, ensuring compliance with all applicable regulatory requirements including Swiss "Heilmittelgesetz, HMG" and "Arzneimittel-Bewilligungsverordnung, AMBV";
- Oversee Good Distribution Practice (GDP) topics under the responsibility of BCC AG, including QA management and QA oversight of processes related to trade in foreign countries;
- Act as Quality Manager for triangulated products, ensuring relevant legislation is considered for all Quality and Compliance tasks pertaining to the position;
- Support the "Fachtechnisch verantwortliche Person, FvP" (Responsible Person, RP) as required by Swiss regulations;
- Guide team members by providing expert quality opinions during deviations, prioritization, problem solving, process implementation with stakeholders, and potential escalations for BCC AG Consumer Health processes;
- Support the preparation and presentation of the quarterly and annual BCC AG Management Reviews;
- Coordinate and facilitate internal and external audits and inspections of the BCC AG;
- Maintain awareness of current GMP and GDP trends, contributing to the management of continuous improvement within the Quality cluster;
- Streamline business processes to maximize efficiencies and resolve discrepancies.
WHO YOU ARE:
- Master’s degree in pharmacy, (Bio-) Chemistry, or equivalent;
- Broad knowledge of GMP and GDP regulations;
- In-depth experience in a GMP/GDP regulated environment (e.g., manufacturing, quality);
- Strong partnering and stakeholder management skills across different business functions and locations;
- Excellent team player and negotiation skills with experience in change management;
- Fluent in English; additional languages are an asset;
- High self-awareness, integrity, and commitment to company values;
- Strong quality and cost awareness, negotiation skills.
YOUR APPLICATION
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Bayer is committed to providing barrier-free access and support-facilities for individuals with disabilities - during the application process and beyond. Applicants with disabilities are encouraged to request any support / equipment they may need via the contact information below.
Location:
Switzerland : Basel-City : Basel
Division:
Consumer Health
Reference Code:
869524
