Pharmaceutical Operations Manager Role
We are seeking a highly skilled Pharmaceutical Operations Manager to join our team. This is an exciting opportunity for someone with a strong background in pharmaceutical manufacturing and quality control.
Job Description:
* The successful candidate will be responsible for managing daily technical aspects related to manufacturing and quality control of our pharmaceutical products, including technology transfer topics, analytical topics, manufacturing processes, Quality Control investigations, and troubleshooting.
* This role also involves regularly writing, reviewing, and approving technical documents such as protocols, reports, and instructions to ensure compliance with current Good Manufacturing Practice (cGMP), QA, and regulatory requirements.
* An additional key responsibility will be to manage MSAT-related Change Controls to ensure timely implementation of changes.
* Other duties include providing expertise on Good Manufacturing Practice (GxP), Quality Control, and pharmaceutical manufacturing matters to internal stakeholders.
* Supporting Regulatory Affairs and Quality Assurance teams by providing technical guidance on GxP, Quality Control, and pharmaceutical manufacturing matters.
* Assessing, interpreting, and providing guidance on analytical methods and techniques related to Active Pharmaceutical Ingredients (APIs) or finished products, such as High-Performance Liquid Chromatography (HPLC), endotoxins, sterility, or other analytical methods.
* Acting as a CMC expert support for manufacturing and Quality Control matters on requests from Regulatory Affairs.
* Maintaining technical exchanges and follow-ups with external partners, including Contract Manufacturers (CMOs), Analytical labs, and API suppliers.
* On occasion, backing up MSAT projects and ensuring timely completion.
* In collaboration with Project Management, ensuring the archiving and classification of MSAT-related documents.
* Participating in routine follow-up of Quality Control activities, including global management of reference standards and ongoing stability studies.
About You:
* A Master's degree in Life Sciences, such as pharmacy, pharmaceutical sciences, chemistry, biotechnology, or a related field.
* Work experience in GMP pharmaceutical manufacturing with a strong awareness of quality assurance aspects. Quality control experience is a valuable asset.
* At least 5 years of proven experience in an operational GMP pharmaceutical environment with combined expertise in manufacturing finished products and analytical expertise.
* Practical experience in managing QA documents derived from operational activities.
* Proven proactivity, autonomy, anticipation, and flexibility within your field of responsibilities.
* Ability to respect cultural differences and develop good relationships with stakeholders from diverse backgrounds.
* Capacity to work on multiple projects simultaneously, demonstrating analytical thinking and organization skills.
* Willingness to travel approximately 5-10% of the time.
* Proficiency in IT tools, including Microsoft Office, Microsoft Projects, and other project management tools.
* A high level of relational and professional ethics and integrity.