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Manager QC Lab Support and Compliance

Exciting new opportunity for an experienced Manager/Team Leader to join our QC Lab support and Compliance team!

Job Description

In this role, you will oversee the responsibilities of the QC Lab Support and Compliance group which includes; developing team members and career path, implement best industry practices, lead and participates in projects, participate in cross-site teams. You will be responsible for completion of personal and team goals / objectives / performance evaluations and you will complete one-to-one assessment with employees and perform performance reviews and will ensure that employees are trained.

You will support innovation, improvements and alignment of the team, and communicate the group’s activities across functional area.

Primary Responsibilities

  • Oversees management related work schedules and ensures completion of deliverables/activities
  • Timely communication to teams for unplanned scheduling changes/issues to other QC staff/management as impacts their teams
  • Escalates appropriately when time lines cannot be met with mitigation plans
  • Ensures team is focused on business and prioritization
  • Situational leadership-ability to flex and respond to unexpected situations/demands; effectively problem solve and reallocate resources as necessary
  • Provide leadership for QC initiatives as related to strategy of the business for example; cross site improvements, lead/participate to drive development of self and teams – overall strategy. Ensures global alignment.
  • Contributes to more complex projects/initiatives either through execution or ensures completion of activities including; reports, project representation (complex or those with significant impact) or management (routine or minimal complexity) through delegation
  • Ensures establishment of goals and development plans for employees
  • Maintain quality metrics for QC Department to ensure optimization and awareness
  • Provide Quality Unit oversight where designated
    Scope includes Laboratory exceptions, deviations, CAPA’s, Alert/Actions, analytical instrument validation, and general compliance oversight

 

Qualifications

  • Proven understanding and appropriate assessment of compliance, risk management, validation
  • Understanding of EU & FDA guidance, knowledge in Stability, BPDR, OOS result handling
  • 4+ years’ experience working with GMP experience and compliance oversight

Education

  • Bachelor’s degree (B.S.) in Life science or Masters degree (M.S.)


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329758389Phoenix-f38382b912018-02-09T17:05:06.273Manager QC Lab Support and Compliance

Exciting new opportunity for an experienced Manager/Team Leader to join our QC Lab support and Compliance team!

Job Description

In this role, you will oversee the responsibilities of the QC Lab Support and Compliance group which includes; developing team members and career path, implement best industry practices, lead and participates in projects, participate in cross-site teams. You will be responsible for completion of personal and team goals / objectives / performance evaluations and you will complete one-to-one assessment with employees and perform performance reviews and will ensure that employees are trained.

You will support innovation, improvements and alignment of the team, and communicate the group’s activities across functional area.

Primary Responsibilities

  • Oversees management related work schedules and ensures completion of deliverables/activities
  • Timely communication to teams for unplanned scheduling changes/issues to other QC staff/management as impacts their teams
  • Escalates appropriately when time lines cannot be met with mitigation plans
  • Ensures team is focused on business and prioritization
  • Situational leadership-ability to flex and respond to unexpected situations/demands; effectively problem solve and reallocate resources as necessary
  • Provide leadership for QC initiatives as related to strategy of the business for example; cross site improvements, lead/participate to drive development of self and teams – overall strategy. Ensures global alignment.
  • Contributes to more complex projects/initiatives either through execution or ensures completion of activities including; reports, project representation (complex or those with significant impact) or management (routine or minimal complexity) through delegation
  • Ensures establishment of goals and development plans for employees
  • Maintain quality metrics for QC Department to ensure optimization and awareness
  • Provide Quality Unit oversight where designated
    Scope includes Laboratory exceptions, deviations, CAPA’s, Alert/Actions, analytical instrument validation, and general compliance oversight

 

Qualifications

  • Proven understanding and appropriate assessment of compliance, risk management, validation
  • Understanding of EU & FDA guidance, knowledge in Stability, BPDR, OOS result handling
  • 4+ years’ experience working with GMP experience and compliance oversight

Education

  • Bachelor’s degree (B.S.) in Life science or Masters degree (M.S.)
2018-03-03T01:53:48.707 Exciting new opportunity for an experienced Manager Team Leader to join our QC Lab support and Compliance team! Job Description In this role, you will oversee the responsibilities of the QC Lab Support and Compliance group which includes developing team members and career path, implement best industry practices, lead and participates in projects, participate in cross-site teams. You will be responsible for completion of personal and team goals objectives performance evaluations and you will complete one-to-one assessment with employees and perform performance reviews and will ensure that employees are trained. You will support innovation, improvements and alignment of the team, and communicate the group s activities across functional area. Primary Responsibilities Oversees management related work schedules and ensures completion of deliverables activitiesTimely communication to teams for unplanned scheduling changes issues to other QC staff management as impacts their teamsEscalates appropriately when time lines cannot be met with mitigation plansEnsures team is focused on business and prioritizationSituational leadership-ability to flex and respond to unexpected situations demands effectively problem solve and reallocate resources as necessaryProvide leadership for QC initiatives as related to strategy of the business for example cross site improvements, lead participate to drive development of self and teams overall strategy. Ensures global alignment.Contributes to more complex projects initiatives either through execution or ensures completion of activities including reports, project representation (complex or those with significant impact) or management (routine or minimal complexity) through delegationEnsures establishment of goals and development plans for employeesMaintain quality metrics for QC Department to ensure optimization and awarenessProvide Quality Unit oversight where designated Scope includes Laboratory exceptions, deviations, CAPA s, Alert Actions, analytical instrument validation, and general compliance oversight Qualifications Proven understanding and appropriate assessment of compliance, risk management, validation Understanding of EU & FDA guidance, knowledge in Stability, BPDR, OOS result handling 4 years experience working with GMP experience and compliance oversight Education Bachelor s degree (B.S.) in Life science or Masters degree (M.S.)11Jobnetf38382b9100000000000IDK_OFIR_02DKDanmark228DKK2018-03-02T00:00:000010https://www.biogen.com/content/corporate/en_us/careers/careers-search.html.html?searchkeyword=&category=&location=0EuropaDanmarkEuropaDanmarkSjælland & øerStorkøbenhavnAllerødEuropaDanmarkSjælland & øerNordsjællandFredensborgEuropaDanmarkSjælland & øerNordsjællandHillerød3106375BIOGEN (DENMARK) NEW MANUFACTURINGApS11Biogen Alle 13400Hillerød77415757DKDanmark155.9220039012.27590210
DKDanmarkDKDanmark
8Fuldtid46Permanent524240JobNet47689591000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=f38382b9https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=f38382b9https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=f38382b9&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=f38382b9&page=EmailApplyForm&component=SendApplicationButton1Dansk3Læse/ tale221201Biokemiker20Ingeniør og naturvidenskab352909409Sine Rosholm Rasmussensrr@star.dkDKDanmarkDKDanmarkda-DK