Alla uppdrag
Compliance/QA Manager TILLSATT
Företaget växer globalt med nya medarbetare och produkter. Man jobbar med specialistläkemedel inom onkologi, nefrologi och immunologi och har en nordisk/baltisk organisation. Nu behöver man utöka med en specialist inom Compliance och Quality Assurance. Du får möjlighet att vara med och påverka i den lilla organisationen.

• Du ska ha erfarenhet från kvalitetsarbete inom marknadsbolag inom läkemedel
• Du kan redan eller vill lära dig arbetet kring det etiska regelverket för läkemedel (godkännande av marknadsföringsmaterial, audit promotion, compliance).
• Du är farmaceut, eller motsvarande, då rollen omfattar ’Responsible Person’ inom de nordiska länderna
• Kunskaper inom regulatory affairs och pharmacovigilance är meriterande.

Som person är du trygg och självständig.
Tjänsten är placerad i Stockholm.

För mer information om tjänsten samt ansökan är du välkommen att kontakta Catharina Bergold, Rekryteringskonsult på Rekryteringsspecialisten AB (tel 070-2179879).
Du är varmt välkommen med din ansökan!


Job Purpose
1. Compliance:
To establish and oversee the quality and compliance of policies and procedures related to the Association of the Nordic/Baltic Pharmaceutical Industry Code of Practice (‘the Code’) across all The Company Nordic/Baltic commercial activities.
To ensure that all relevant materials and activities developed by Nordic/Baltic Commercial are in accordance with The Company policies, guidelines and procedures and applicable regulations including national and international Codes of Practice.
To identify new process and amend others to ensure effective business objectives are met whilst improving Code compliance.
Baltic & Iceland compliance will be handled through coordination with a local third party.
Key Responsibilities:
• Develop, refine and implement all policies and procedures pertaining to the Code and other relevant Nordic/Baltic Commercial activities
• Ensure that The Company Nordic/Baltic staff are provided with the appropriate ongoing training to ensure compliance with both the Nordic/Baltic Pharmaceutical Code and Nordic/Baltic Pharmaceutical Commercial Policies and Procedures
• Facilitate internal audits to assess adherence to Nordic/Baltic Commercial policies and procedures and Nordic/Baltic Pharmaceutical Compliance
• Work closely with the sales and marketing teams to agree complaint business strategies and initiatives
• Act as a central point of Nordic/Baltic Pharmaceutical Code expertise and advice for all The Company staff
• Manage the Nordic/Baltic Medical Information service together with Medical including:
o Ongoing training and coaching of Medical Information
o Management of contractors providing Medical Information services
• Act as a Commercial Final Signatory for Nordic/Baltic materials
• Investigate breaches of the Code or Nordic/Baltic Commercial SOPs in line with departmental procedure
• Manage complaints made or received under the Code

Job Purpose
2. Ant-Bribery Manager:
To ensure correct anti-bribery global and regional processes and training are implemented. To follow correct reporting of breaches to the Anti-Bribery Global policy.
Key Responsibilities:
1. Communication:
• Effectively communicate corporate anti-bribery messages to all staff and those representing the Company.
2. Education & Training:
• Using corporate templates add local requirements to produce robust locally compliant materials.
• Ensure training is delivered effectively and to the necessary timetable.
3. Reporting & Compliance System:
• Maintain the incident reporting system and escalate all relevant cases in line with anti-bribery procedures. Ensure all reporting procedures are available to staff and those representing the Company.
4. Risk Management:
• Highlight any potential risks to the Global Anti-Bribery Manager. Proactively identify potential risks.
Other Activities:
• Feedback on the effectiveness of the anti-bribery programmes and recommend improvements.
• Work with other Anti-Bribery Managers to develop best practice.

Job Purpose
3. QA/Responsible person:
Key Responsibilities:
Responsible for the Quality System within the company related to Wholesale Trade and Good Distribution Practice (GDP).
• Ensure that the provisions of the Wholesale Trade’s Licence (WL) are observed in accordance with Technical Agreements and notify The Company if any changes are required to the WL.
• Ensure that Medicinal Products are not released for sale and supply until they have been formally released against the requirements of the Marketing Authorisation (MA) and Good Manufacturing Practice, (GMP) by a Qualified Person (QP) in accordance with Technical Agreements.
• Ensure that Medicinal Products are stored and distributed in accordance with the requirements of the MA and GDP to ensure that their quality is not compromised in accordance with Technical Agreements.
• Ensure that the Quality System incorporates Standard Operating Procedures (SOPs) covering GDP requirements and that the procedures are maintained.
• Have access to all areas, sites, stores and records related to the WL activities.
• Regularly review and monitor all such areas or have delegated arrangements where written reports are received confirming that actions have been carried out.
• Oversee the Quality System and auditing of the Quality System and request written reports from personnel performing delegated duties on behalf of the RP. Review of the Quality System should include accuracy and quality of records, compliance with established SOPs, the quality of handling and storage equipment and facilities and the standards achieved.
• Ensure that records related to activities detailed in SOPs are maintained to demonstrate execution of the activities.
• Ensure training programs are in place for all personnel involved in GDP activities.
• Carry out all delegated duties at least on an annual basis.
• Ensure that records are maintained relating to the discharge of RP duties.
• Ensure Technical Agreements are implemented for sub-contracted activities

Key Competencies specific to the roles:
• University degree in Pharmaceutical Sciences or equivalent
• Experience from quality assurance within the pharmaceutical industry
• Working experience of Quality Systems
• Knowledge of relevant laws, practices and regulations (within QA/Compliance/Anti-Bribery)
• Knowledge of relevant therapeutic areas is a merit
• Be recognized as a well-respected manager with a high level of integrity.
• Experience in translating corporate strategies into a local context.
• Working within the local affiliate organisation, or ability to have oversight of affiliate organisation.
• Meeting of local requirements, e.g. residency in local country, and fluency in local working languages.
• Excellent organisational and communication skills
• Ability to multi-task
• Good skills in English, both verbal and written, as well as proficiency in the Scandinavian languages
• Highly ethical with honesty and integrity character traits.
• Strong character to advise senior management and stand for what is right against adversity