Operational QA Manager
GSK is currently looking for an Operational Quality Manager to join our team in Rockville, MD.
OQ Manager will be responsible for Operational Quality s day to day activities at LSM/SSM site including batch record review and day to day Quality Operations.
The OQ Manager will manage a team of Quality professionals accountable for batch record reviews confirmation of GMP operations in production and support groups i.
e.
laboratory and engineering.
The job holder will be the main liaison with production management team and will participate in daily planning meetings, approve deviations to processes, to support LSM/SSM activitiesKey
Responsibilities:
Manage team of Operational Quality professionals (24/7) to support production activities and shop floor presenceEnsure Operational Quality schedules and activities support batch record review and batch disposition needs Review and approve deviation reports, corrective actions, to support GMP decisions and material disposition.
Review and approve SOPs, batch records, forms and all other GMP documentation to support day to day operations With the Operational Quality Associate Director, the OQ Manager will serve as QA representative at product team meetings (PTM, CMC, POMM), participate in facility design teams and specific drug product development teamsSupport Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employeesEnsure that Quality risks in productions areas are understood and appropriately mitigate to support production schedules Actively support performance initiatives to support performance improvements in the BDS release area to achieve site service goals.
Why you?Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS Degree5
years in a GMP pharmaceutical environment2
years of Quality Assurance, Quality Control or Operational Control experiencePreferred
Qualifications:
If you have the following characteristics, it would be a plus:
Biopharm experience preferred2
years supervisory experience strongly preferredExperience managing deviations and changes to processes as author, reviewer, or approverKnowledge in Performance Improvements tools i.
e.
Six Sigma or equivalentAbility to interpret and apply GMP, ICH and other regulatory guidelines.
Critically evaluate individual processes and projects, then synthesize their insights to arrive at a summary of overall organizational statusExcellent organization skills - spearhead both the planning and implementation stages of multiple projectsEffective oral and written communication skills - able to speak, actively listen, and write/present well to different levels of the organizationSound leadership skills and the ability to work effectively in a cross-functional team environment; Ability to manage appropriate resources (personnel, projects, budget, etc) toward accomplishment of department and corporate goals.
Ability to handle multiple projects and interface with individuals from various departments at various levels.
Ability to work in a fast-paced environment in a results-oriented fashion.
Technical expertise a firm understanding and application of process improvements, Biopharm technical elements and Quality Compliance requirements for the role.
Organization skillsLeadership skills coach and company game-changer, inspiring other team members to give their best effort and setting the direction for improvement initiatives#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements.
For more information, please visit GSK s Transparency Reporting For the Record site.
SummaryLocation:
USA - Maryland - RockvilleType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
OQ Manager will be responsible for Operational Quality s day to day activities at LSM/SSM site including batch record review and day to day Quality Operations.
The OQ Manager will manage a team of Quality professionals accountable for batch record reviews confirmation of GMP operations in production and support groups i.
e.
laboratory and engineering.
The job holder will be the main liaison with production management team and will participate in daily planning meetings, approve deviations to processes, to support LSM/SSM activitiesKey
Responsibilities:
Manage team of Operational Quality professionals (24/7) to support production activities and shop floor presenceEnsure Operational Quality schedules and activities support batch record review and batch disposition needs Review and approve deviation reports, corrective actions, to support GMP decisions and material disposition.
Review and approve SOPs, batch records, forms and all other GMP documentation to support day to day operations With the Operational Quality Associate Director, the OQ Manager will serve as QA representative at product team meetings (PTM, CMC, POMM), participate in facility design teams and specific drug product development teamsSupport Data Integrity and Human Performance efforts to reduce incidents and increase engagement with employeesEnsure that Quality risks in productions areas are understood and appropriately mitigate to support production schedules Actively support performance initiatives to support performance improvements in the BDS release area to achieve site service goals.
Why you?Basic
Qualifications:
We are looking for professionals with these required skills to achieve our goals:
BS Degree5
years in a GMP pharmaceutical environment2
years of Quality Assurance, Quality Control or Operational Control experiencePreferred
Qualifications:
If you have the following characteristics, it would be a plus:
Biopharm experience preferred2
years supervisory experience strongly preferredExperience managing deviations and changes to processes as author, reviewer, or approverKnowledge in Performance Improvements tools i.
e.
Six Sigma or equivalentAbility to interpret and apply GMP, ICH and other regulatory guidelines.
Critically evaluate individual processes and projects, then synthesize their insights to arrive at a summary of overall organizational statusExcellent organization skills - spearhead both the planning and implementation stages of multiple projectsEffective oral and written communication skills - able to speak, actively listen, and write/present well to different levels of the organizationSound leadership skills and the ability to work effectively in a cross-functional team environment; Ability to manage appropriate resources (personnel, projects, budget, etc) toward accomplishment of department and corporate goals.
Ability to handle multiple projects and interface with individuals from various departments at various levels.
Ability to work in a fast-paced environment in a results-oriented fashion.
Technical expertise a firm understanding and application of process improvements, Biopharm technical elements and Quality Compliance requirements for the role.
Organization skillsLeadership skills coach and company game-changer, inspiring other team members to give their best effort and setting the direction for improvement initiatives#LI-GSKPlease visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK? Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose to unite science, technology and talent to get ahead of disease together so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it s also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ AgenciesGSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements.
For more information, please visit GSK s Transparency Reporting For the Record site.
SummaryLocation:
USA - Maryland - RockvilleType:
Full time.
Estimated Salary: $20 to $28 per hour based on qualifications.
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