Associate Director, GMP Biologics Quality Assurance Waltham,
Job description Site Name: USA - Massachusetts - Waltham
Posted Date: Sep 1 2020
Are you looking for a Quality leadership role that allows you to
leverage your technical knowledge/experience for strategic
advantage? If so, this Associate Director, Biologics QA role could
be an exciting opportunity to explore.
As the AD, Biologics QA you will be responsible for partnering
internally/externally with Analytical Development, QC, and
Stability functions to: provide necessary QA oversight; work with
and influence Contract Testing Labs; support the analytical
lifecycle of assigned assets; identify and implement continuous
improvement opportunities .
This role will provide YOU the opportunity to lead key
activities to progress YOUR career. These responsibilities include
some of the following:
Manage Specialty API, bulk drug substance, analytical testing,
drug product, and/or packaging external manufacturing quality
assurance operations and compliance activities with leadership and
direction of R&D project team(s) and Pharma Supply Chain (PSC)
supply, technical and specialty product team(s).
Provide and/or facilitate decisions concerning the quality of
material disposition or rejection.
Responsible for the Operational Quality management relationship
with strategic partners, alliances & external supply contractors
for Specialty products.
Responsible for assuring timely supply of product & maintenance
of GSK reputation from a quality perspective.
Contribute to the establishment of GSK Quality Standards for
products within the scope of Specialty External Manufacturing.
Manage issues and risks identified in area of
Posting End Date: EOD, Monday, September 7
Recommend and manage implementation and continuous improvement
of quality processes and procedures required to ensure GMP
expectations for GSK external suppliers are met.
Build & maintain trusting relationship with external partners
whereby influence can be applied & accepted to assure GSK quality
standards are met.
Establish, implement and sustain an operational quality
oversight model in compliance with GSK quality expectations &
accounting for contractual complexities & strategic project
Supports the governance structure for quality oversight of
External Suppliers that assures GSK product are in compliance with
registered detail, QMS requirements and Specialty External
Directly manages external suppliers as assigned.
Manage activities to ensure on time/Right First-Time testing and
disposition of bulk drug substance & finished product manufactured
by External Suppliers to meet supply chain demand.
Assure quality issues are managed to safeguard GSK's patients,
ensure business continuity & protect reputation.
Contribute to and manage implementation of quality strategy from
the QMS or from project leads as applicable.
Where deviations from the above policies or the manufacturing
process occur, e.g. registered detail, resolve, mitigate or
escalate to senior management as judged necessary
Actively manage records produced by External Suppliers, to
ensure timely and appropriate outcomes for Quality and Production
Develop/negotiate or maintain quality agreements as required by
Assurance that GSK's Quality Management System is applied to
External Supply practices demonstrated through effective Quality
Agreements, GSK Corporate audits & delivery of successful
Assist External Suppliers with inspection preparedness planning
including identification and development of storyboards, coaching
and identification of specific inspectional risks.
Report and drive resolution of cGMP/Regulatory compliance
issues. Request required legal documentation such as Certificate of
Pharmaceutical Products (CPP), GMP certificate, Legalized and
Notarized Declarations and documents as required by for LOCs.
Build and maintain good working relationships with internal
partners, through compliance with applicable SOPs, Technical Terms
of Supply and Service Level Agreement as applicable.
Maintain regular dialog with team members, individually and
collectively, providing feedback and recognition. Monitor the
training status of direct reports
Resolution, mitigation or rapid escalation of issues impacting
quality, safety or efficacy of Specialty products.
Support Product Incident Alerts, Stock Recoveries and Product
Recalls; Serve as Issue Management/Product Incident Recall
Assist in development of budget as requested.
Why you? Basic Qualifications: We are looking for professionals
with these required skills to achieve our goals:
Bachelor Degree in Science or Engineering discipline and minimum
8 years experience in a relevant QC, Analytical Method
Qualification/Validation, Stability, or Quality Operations role -
OR – Masters Degree and minimum 6 years experience in a relevant
QC, Analytical Method Qualification/Validation, Stability or
Quality Operations role.
> 8 years of previous Pharmaceuticals industry experience in
technical or quality role(s) with at least 2 years of experience in
support of biopharmaceuticals, biologics or vaccines.
Direct experience in analytical method qualification/validation
and/or stability operations and Quality Assurance roles.
Experience with quality systems and quality control
Experience with GMP's, FDA, EU and other regulatory agency
requirements pertaining to quality and compliance for biological
product and facility licensing requirements.
Experience applying quality and risk management principles and
Preferred Qualifications: If you have the following
characteristics, it would be a plus:
> 3 years of operational quality assurance or compliance
2+ years experience managing the implementation and continuous
improvement of quality processes and procedures for external
suppliers to ensure GMP expectations are met.
Demonstrated problem solving skills.
Demonstrated ability to make grade level decisions based on
facts and data and application of risk management principles.
Experience with work related travel.
Excellent written and oral communication skills -English.
Proficient presentation skills.
Proven ability to manage teams.
Strong influencing and negotiating skills.
Demonstrated ability to develop and coach staff.
Capable of managing across boundaries.
Why GSK? Our values and expectations are at the heart of
everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity
along with Courage, Accountability, Development, and Teamwork. As
GSK focuses on our values and expectations and a culture of
innovation, performance, and trust, the successful candidate will
demonstrate the following capabilities:
Agile and distributed decision-making – using evidence and
applying judgement to balance pace, rigour and risk.
Managing individual and team performance.
Committed to delivering high quality results, overcoming
challenges, focusing on what matters, execution.
Implementing change initiatives and leading change.
Sustaining energy and well-being, building resilience in
Continuously looking for opportunities to learn, build skills
and share learning both internally and externally.
Developing people and building a talent pipeline.
Translating strategy into action - a compelling narrative,
motivating others, setting objectives and delegation.
Building strong relationships and collaboration, managing
trusted stakeholder relationships internally and externally.
Budgeting and forecasting, commercial and financial acumen.
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/ Agencies
GSK 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
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
Associate Director, GMP Biologics Quality Assurance Full-Time,
Waltham, Massachusetts, United States Associate Director, GMP
Biologics Quality Assurance Full-Time, Waltham, Massachusetts,
United States Start a career with purpose GSK is a place where
outstanding people do amazing things. As a science-led global
healthcare company, we exist to help people do more, feel better,
Annual bonus based on company performance
Long term incentives and pension plan
Learning and career development
Access to healthcare & wellbeing programmes