QA Operations Team Manager
Gdańsk

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

At this position you will manage the team in the Quality Operations Department. You will be tasked with motivating employees and supporting them with substantive knowledge and expertise in the field of regulatory provisions. You will assist Quality Operations Head in developing, implementation and supervising the operation of the Quality Management System in the Quality Operations Department. Last but not least you will participate in the preparation of Polpharma Biologics S.A. for pharmaceutical inspections and audits carried out by domestic and foreign regulatory authorities by ensuring the correct conduct of processes for which the Quality Operations Department is responsible, including the batch documentation assessment process.

Your responsibilities

  • Supervision over the proper preparation of the required GMP documents and their review;
  • Assessment and approval of the Quality Management System documentation prepared by Polpharma Biologics or prepared by contractors and/or external companies;
  • Development and updating of system documentation;
  • Approval of documentation related to the process and product (protocols, reports, etc.);
  • Verification of compliance of the GMP documentation in the unit with internal and external regulations before its implementation;
  • Maintaining and developing the quality system in consultation with the Managing Quality Compliance and Operational Quality Compliance Departments;
  • Verification of production processes for compliance with GMP requirements through regular visits in the production area;
  • Review and approval reported deviations, OOX and complaints in accordance with the procedures in force, according to legal requirements;
  • Conducting and/or participating in internal and external audits;
  • Participation in change control processes, ensuring that the proposed changes comply with GMP requirements and that the management of changes is carried out in accordance with the internal procedures of Polpharma Biologics;
  • Participation in risk analysis and deviation management processes, including investigation, in compliance with internal procedures of Polpharma Biologics;
  • Fulfillment of duties in accordance with current GMP regulation and other pharmaceutical guidelines;
  • Fulfilling tasks assigned by the supervisor;
  • Supervision and active participation in solving quality problems and preventing their occurrence;
  • Participation in organization, implementation, systematic assessment of effectiveness and improvement of the quality system in accordance with current legal requirements, including GxP requirements, in the scope covered by the medicinal products and imported medicinal products license;
  • Informing the supervisor about qualitative problems, negative trends, audit observations, especially if they may affect patient safety, quality and efficacy of medicinal products;
  • Project management in terms of responsibilities;
  • Participating in processes related to the recall and/or withdrawal of the medicinal product or the investigational medicinal product from the market;
  • Participates in the preparation for audits and inspections in Polpharma Biologics;
  • Conducting internal training in scope of quality assurance and GxP for company employees at all levels of management;
  • Development and supervision of the proper use of the budget and human resources in the subordinate team;
  • Directing and providing support to subordinate employees and ensuring conditions enabling them to improve their qualifications and proper performance of duties.

If you have

  • University degree in biology, chemistry, pharmacy, biotechnology or related;
  • 5 years of working experience in the pharmaceutical industry, including 2 years in the evaluation of pharmaceutical products in the area of control or quality assurance as well as in team management;
  • Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to pharmaceuticals, specifically in the ICH environment;
  • Knowledge of Quality Management Systems;
  • Fluent English;
  • Ability to work with MS Office;
  • Ability to make decisions;
  • Ability to work as a part of a team as well as being a leader;
  • Knowledge of the manufacturing technology of pharmaceutical products and analytical methods related to their assessment.

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan;
  • Relocation package;
  • International work environment;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]

INFORMATION ON PERSONAL DATA PROCESSING

 

By sending the data contained in the recruitment notice and the application documents (in particular the application form, CV, cover letter and references), you consent to the processing of your personal data that you have given voluntarily, other than your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history, by Polpharma Biologics S.A., with its registered office in Gdańsk at 3 Trzy Lipy Street, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000763945, waste database: 000120346, TIN: 9571112470, fully paid-up share capital: PLN 875,000,000.00; (hereinafter: “Employer”)for the purpose of conducting the current recruitment process, i.e. assessing your qualifications, as well as the abilities and skills that are needed for working in the specific position for which you are applying – for 12 months.


In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation; hereinafter “GDPR”), we would like to inform you that:

 

1.The Controller’s identity

 

1.1. Current recruitment process

 

The controller of your personal data which is being processed in the current recruitment process is the Employer. 

 

1.2. Future and other pending recruitment processes – database of candidates


Additionally, you may agree to your data being saved in the candidate database used by the Polpharma Biologics Group companies for 36 months.  In such a case, the Joint Controllers of your personal data will be the companies from the Polpharma Biologics Group, i.e.:

 

  • Polpharma Biologics S.A., with its registered office in Gdańsk at 3 Trzy Lipy Street, 80-172 Gdańsk, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000763945, waste database: 000120346, TIN: 9571112470, fully paid-up share capital: PLN 875,000,000.00; 


  • Polpharma Biologics Warsaw Sp. z o.o., with its registered office in Duchnice, at 4 Spółdzielcza Street, 05-850 Duchnice, postal district Ożarów Mazowiecki, which is entered into the register of entrepreneurs of the National Court Register under the number: 0000498732, TIN: 1182096979, waste database number: 000476915, share capital: PLN 349,835,000.00; 


  • Polpharma Biologics Utrecht B.V.. with its registered seat in Utrecht, The Netherlands, and its offices at Yalelaan 46, 3584 CM Utrecht, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 58858466; 


  • Polpharma Biologics Group B.V., with its registered seat in Amsterdam, The Netherlands, and its offices at Herengracht 458, 1017 CA Amsterdam, The Netherlands, registered with the Dutch Chamber of Commerce under registration no: 76391825.  

(hereinafter also referred to as: the “Joint Controllers”);

The companies will act as Joint Controllers with regard to keeping a common database of potential job candidates of the Company mentioned above.  The database operated by them is managed by Polpharma Biologics S.A.

If your application is considered within future or other pending active recruitment processes, the Joint Controller conducting the recruitment will act in this respect as a separate controller, processing data on the principles described in this clause.  

2. Contact details

2.1. Personal data protection

You can contact each of the controllers on all matters regarding personal data protection, in order to exercise your rights by sending an e-mail to: [email protected]


2.2. Other matters regarding recruitment


Please contact us at [email protected] in other recruitment matters.


3. Objectives of and grounds for processing personal data


3.1. Active recruitment process – including the current recruitment


A. In the case of the processing of your personal data within an active (including current) recruitment process, your personal data will be processed to hold the recruitment process that is being conducted, i.e. to assess your qualifications, as well as the abilities and skills that are needed to work in the position for which you are applying, and in order to select a suitable person for that position – on the basis of:

  • Article 6(1)(c) GDPR, i.e. the processing is necessary for fulfilling the controller’s legal obligation arising from the provisions of labour law (in particular Article 221 1 of the Labour Code) with regard to the following personal data: your forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications and career history;


  • Article 6(1)(a) GDPR, i.e. on the basis of your voluntarily given consent with regard to the other personal data you have voluntarily provided in your application documents (in particular in your CV, your cover letter and your references);

  • Article 6(1)(b) GDPR, i.e. processing is necessary to take steps at your request before entering into a contract (applies to recruitment for positions where the Employer enters into cooperation with the candidate on the basis of a legal relationship other than an employment relationship);


  • Article 6(1)(f) GDPR, i.e. the processing is necessary for the purposes of the legitimate interests pursued by the controller, because of the possibility of contacting candidates even after the end of the recruitment process, if a person who qualified for the position does not take the job or the employment contract concluded with him/her is terminated within 12 months of the end of the recruitment process;


  • Article 6(1)(f) GDPR, i.e. the processing is necessary for the purposes of the legitimate interests pursued by the controller – establishment, assertion or defence against possible claims between you and the data controller (with regard to all personal data you provided).



B. Your provision of your personal data as specified in Article 221 § 1 of the Labour Code (i.e. forename(s), surname, date of birth, contact details, academic qualifications, professional qualifications, employment history) arises from the statutory obligation to collect such data from people applying for employment, as specified in the Labour Code. It is necessary for you to be able to participate in the active recruitment process.  The consequence of failing to provide this data is the inability to participate in the active (including the current) recruitment process. 


C. The provision of other personal data is voluntary and does not constitute a condition for participation in the active (including current) recruitment process.



3.2. Processing personal data in the database of candidates


A. If you give your consent to the processing of your data in the database of candidates for the purposes of future or other pending recruitment processes, your personal data will be processed in order to keep a database of candidates for conducting future or other pending recruitment processes, i.e. assessing your qualifications as well as the abilities and skills that are needed to work in the position for which the recruitment is being conducted, and selecting a suitable person to work in that position – on the basis of:

 

  • Article 6(1)(a) GDPR, i.e. your freely given consent – with respect to all personal data provided by you;

 

B. The provision of your personal data and your consent to the processing of all your personal data in order to take part in future recruitment processes is voluntary, but it is a condition for the inclusion of your personal data in the above database which is kept for the purposes of future recruitment processes.


4. Categories of recipients of personal data

4.1. Your personal data may be disclosed to the following entities: employees and associates of the data controller, entities handling recruitment processes for it and on its behalf, IT service providers, as well as entities providing advisory and legal services and other entities from the Polpharma Biologics Group.


4.2. Your personal data may be disclosed to entities and authorities that are authorised to process such data by law.


4.3.
The controller does not intend to transfer your personal data to countries outside the European Economic Area or to an international organisation. However, in certain situations related to personal data processing, data may be transferred outside the EEA. Personal data may only be transferred outside the EU or EEA either to countries that the European Commission has found to guarantee an adequate level of data protection or with appropriate safeguards, in particular through the use of EU Standard Contractual Clauses.  In such cases, you may request a copy of these respective safeguards, in particular the EU Standard Contractual Clauses (if applicable), or the specification of where your data has been sent, by writing to: [email protected]

 

5. Period of personal data storage

5.1. Active recruitment process – including the current recruitment

1. Your personal data will be processed:

  • for 12 months from the date of your application being considered for the particular recruitment process or
  • until you raise an objection which is accepted (if the processing is based on the controller’s legitimate interest) or until you withdraw your consent (if the processing is based on the consent that has been given)

 whichever is the earlier.

5.2. Processing personal data in the database of candidates


1. Your personal data will be processed:

  • for 36 months from the date of your consent to the processing of your personal data for future recruitment processes
  • until you withdraw your consent 

whichever is the earlier.


6. Rights


6.1.
You have the right to access your personal data and to demand its rectification, erasure or the restriction of its processing. 


6.2.
You have the right of data portability, i.e. to receive your personal data, which you have provided to
the personal data controller, in a structured, commonly used and machine-readable format. You may request the data controller to send this data to another controller.


6.3.
To the extent to which the processing of your personal data is based on your consent, you have the right to withdraw that consent. The withdrawal of consent shall be without prejudice to the lawfulness of the processing that was conducted on the basis of the consent before its withdrawal.


6.4
. You have the right to object to the processing of your personal data to the extent to which the basis for the processing of your personal data is a premise of the legally justified interest of the data controller.


6.5. 
You may contact the data controller to exercise the above rights by sending an e-mail to: [email protected]


6.6.
You have the right to file a complaint with the personal data protection supervisory authority (the president of the Personal Data Protection Office – Prezes Urzędu Ochrony Danych Osobowych) if you believe that the processing of your data is breaching the provisions of the law.


7. References


7.1.
If you provide information to us about other people, such as contact details for people who can provide references, you declare that these people have been informed of this and that they agree to the provision of their details.


7.2.
 If you are the designated contact person for providing references for the job candidate, your personal data, such as contact details will be processed for the purpose of obtaining information on the candidate’s qualifications under Article 6(1)(f), i.e. the legitimate interest of the controller, on the terms specified in this document (with the exception of the provisions of clause 3). We may also process information related to your credentials – such as the place of your employment, information about your professional relationship with / knowledge of the candidate and your opinions about him/her. We may obtain this information directly from you, from the candidate or from publicly available sources.  If we obtain data directly from you, the provision of such data is voluntary. 



8. Automated decision-making


8.1
No decisions will be made with respect to you in an automated manner, including as a result of profiling.