Senior Manager Corporate Quality Compliance Job at Amgen

Quality Compliance - Senior Manager

Join Amgen’s Mission of Serving Patients. In this vital role you will be respons...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
12 to 15 years in Pharmaceutical and/or Biotechnology in Quality and/or Manufacturing experience
Lead Auditor Certification
Audit Experience in Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
Strong communication skills both verbal and written
Domestic and International travel up to 50%

Job Responsibility

Coordinates, leads, or participates in Corporate Quality Compliance Audits of Corporate Quality Management System, Amgen sites, Contract facilities, Affiliates, and Critical Service providers
Assesses state of compliance with appropriate regulations and lead or participates in the assessment of action plans to correct deficiencies
Implements risk assessments
Ensure completion, maintenance and sustainability of the assigned training per specific roles to support the audit process
Provides leadership toward calling out site and multi-site compliance issues resulting from audit findings
Serves as subject matter expert on global regulated requirements and inspectional commitments
Provides support for domestic and international Regulatory Authority Inspections when necessary
Provides technical support/compliance review of multi-site/global documents resolving compliance issues
Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations
Alerts senior and/or executive management of significant quality, and compliance risks

What we offer

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

Fulltime

Audit Quality - Corporate Reporting Advisory Senior Manager

An opportunity for a talented, high performing and ambitious Senior Manager to j...

Location

United Kingdom , London; Greater Manchester; Leeds; Birmingham; Reading

Salary:

Not provided

BDO UK LLP

Expiration Date

Until further notice

Requirements

ACA/ICAS qualified or overseas equivalent
Senior Manager in a technical team or other relevant experience in technical financial reporting
Strong working knowledge of IFRSs, UK GAAP, and the Companies Act
Sector specialism for financial services, particularly Banking and Alternative Finance, Fintech or Insurance
Knowledge of the content requirements for the annual report of a company listed on either the Main Market or the AIM market of the London Stock Exchange
Knowledge of the wider financial reporting environment, including future developments in law, regulation and emerging areas
Practical experience of performing technical reviews of annual reports of listed companies
Proven ability to apply technical knowledge to complex financial reporting issues and provide practical and supportable solutions
Strong oral and written communication skills, and an ability to adapt as appropriate to the scenario
Ability to create productive relationships across the firm and network and to influence other senior professionals

Job Responsibility

Work with Managers, Senior Managers, Directors and Partners within both AQD, the Audit Stream and across the wider firm
Maintain and encourage an open and constructive environment in which to provide technical accounting support and advice
Bring pre-existing financial services specialist technical accounting knowledge, and experience to the CRT team and contribute to all output areas
Provide support and supervision to the more junior team members
Technical review of a personal portfolio of annual reports of publicly traded and other higher risk companies, working with the audit team to confirm compliance with financial reporting standards, company legislation and regulatory requirements
Providing clear and practical solutions to the most complex technical financial reporting queries, and act as a consultant for the more junior members of the team in your specialist area
Preparing and presenting financial reporting training, updates and seminars both internally and externally
Helping to develop financial reporting tools and guidance for application by the firm’s partners and staff
Writing articles and other publications on financial reporting matters for internal and external communications
Assisting with the preparation of draft responses to external consultations in relation to legal, regulatory and financial reporting matters

What we offer

Health and wellness programmes
Pension plan with matched employer contributions
Private medical access for you and your family
Income protection plan
Holiday purchase scheme (up to 10 additional days)
Bike to work scheme
Agile working
Career development programmes, resources, and frameworks
Mentoring and coaching
State-of-the-art collaboration spaces

Corporate Tax Manager/ Senior Manager

A top 40 accountancy practice is seeking an experienced Corporate Tax profession...

Location

United Kingdom , Cambridge

Salary:

55000.00 - 75000.00 GBP / Year

Butler Rose

Expiration Date

Until further notice

Requirements

Extensive experience in corporate tax, with a proven track record in a managerial or senior managerial role
Strong technical knowledge with the ability to provide strategic advice on complex matters
Excellent interpersonal and communication skills, able to inspire confidence in clients and colleagues
Proven leadership and team management abilities, with a commitment to mentoring staff
Highly organised with the ability to manage multiple priorities effectively
Professional qualification such as CTA or ACA with relevant tax experience
Proficiency in tax software and solid understanding of accounting and financial principles

Job Responsibility

Manage a varied portfolio of corporate tax clients, delivering high-quality compliance and advisory services
Lead complex corporate tax engagements, including M&A transactions, restructures, group reorganisations, succession and exit planning, and share option schemes
Review and approve corporate tax computations and ensure technical compliance across the team
Build strong client relationships, acting as a trusted advisor and identifying opportunities for additional services
Stay current with tax legislation, providing insights to clients and team members to optimise planning opportunities
Mentor and support team members, providing guidance, technical advice, and feedback
Contribute to the strategic direction of the corporate tax function, including process improvements and business development initiatives
Represent the firm at client meetings, industry events, and other external engagements

What we offer

Opportunity to influence and shape the future of the tax function
Collaborative and supportive environment that encourages innovation and professional growth
Exposure to a broad and diverse client base, offering varied experiences and challenges
25 days' annual leave plus bank holidays
Workplace pension and employee benefits scheme including retailer discounts
Life assurance and access to an Employee Assistance Programme (EAP)

Senior Manager Quality Assurance: Incoming Quality and Warehouse

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

United States , New Albany

Salary:

144021.45 - 194852.55 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
Master's degree and 6 years of Quality/Manufacturing/Engineering experience
Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Lead and participate in Quality Risk Assessments
Provide Quality input to support project or operational design decisions
Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties

What we offer

health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
discretionary annual bonus program
stock-based long-term incentives
award-winning time-off plans
flexible work models where possible

Fulltime

Senior Manager, Clinical Operations/ Senior Global Trial Manager - FSP

Parexel are currently recruiting for an experienced Global Study Operations Mana...

Location

Italy; United Kingdom , Remote; Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum of 7 years of relevant clinical trial management experience
Global trial management experience is essential
Experience managing CRO outsourced studies is essential
Excellent leadership, communication, and organizational skills
Able to multi-task under limited direction and on own initiative
M.S/M.A/Ph.D or B.A/B.S/nursing degree is essential
Prior and demonstrable experience working at a senior level within Study start up preferred

Job Responsibility

Accountable for the end-to-end clinical trial delivery
Providing operational leadership and oversight of cross-functional deliverables
Leading a cross functional trial team to build and deliver the trial operational plan
Responsible for leading the Cross functional trial team to influence and execute delivery of the operational plan and for end-to-end trial execution
Accountable for overall trial delivery, budget, timelines, quality, and milestones
Oversight of all aspects of CRO/vendor identification, set up, statement of work creation, budget oversight and performance (KPI’s and metrics)
Proactively ensure that trial deliverables and milestones are met according to corporate and study-level goals
Identify risks and ensure mitigations and contingencies are being initiated and followed through
Ensure trial Is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes
Participate in preparation for, and conduct of, Health Authority Inspections and internal QA audits

Senior Quality Manager

The Senior Quality Manager will be responsible for planning, coordinating, and d...

Location

United States , Oshkosh

Salary:

Not provided

Energy Systems

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Engineering, Operations Management or Industrial Technology
7 years of progressive Engineering experience with a focus on quality management
3 years of experience leading, mentoring and coaching individuals and teams.

Job Responsibility

Lead a multi-year quality transformation, advancing the facility from Quality Control to Quality Assurance to operational excellence
Set and uphold quality standards to meet customer, regulatory, and Generac Quality Management System requirements
Own plant quality outcomes, including customer experience metrics, cost of quality reduction, compliance, and continuous improvement
Partner cross-functionally with plant, corporate quality, and suppliers to resolve issues and improve product and process quality
Establish quality goals, metrics, inspection/test methods, and standard tools
drive root-cause analysis and corrective actions
Report quality performance to senior leadership and customers while coaching teams and managing resources to achieve objectives

What we offer

Competitive Benefits: Health, Dental, Vision, 401k and many more
State-of-the-art facility with an onsite gym, walking trails, café, free parking and many employee activities
Scheduled events throughout the year that allow our employees, both current and retirees, to gather together and enjoy their time with their families and co-workers
Pride! When a storm strikes, Generac employees always rise to the occasion. Each time a storm hits, many employees volunteer their time with the customer support team or on the production line, while others go right into storm-affected areas to repair generators
Make a positive impact. Generac has always been community-minded and dedicated to giving back. The company proudly offers a Volunteer Time Off program, inviting team members to participate in charitable volunteer opportunities on company time
We believe in having fun. From minor celebrations to major events, our employees balance their work by building a strong culture of teamwork and collaboration through a variety of occasions, including our Fun Days
We’re an inclusive company that celebrates differences and keeps equity and respect at the forefront

Fulltime

Senior Manager Quality

The Senior Quality Manager will be responsible for planning, coordinating, and d...

Location

United States , Beaver Dam

Salary:

Not provided

Energy Systems

Expiration Date

Until further notice

Requirements

Bachelor’s Degree in Engineering, Operations Management or Industrial Technology
7 years of progressive Engineering experience with a focus on quality management
3 years of experience leading, mentoring and coaching individuals and teams.

Job Responsibility

Lead a multi-year quality transformation, advancing the facility from Quality Control to Quality Assurance to operational excellence
Set and uphold quality standards to meet customer, regulatory, and Generac Quality Management System requirements
Own plant quality outcomes, including customer experience metrics, cost of quality reduction, compliance, and continuous improvement
Partner cross-functionally with plant, corporate quality, and suppliers to resolve issues and improve product and process quality
Establish quality goals, metrics, inspection/test methods, and standard tools
drive root-cause analysis and corrective actions
Report quality performance to senior leadership and customers while coaching teams and managing resources to achieve objectives

What we offer

Competitive Benefits: Health, Dental, Vision, 401k and many more
State-of-the-art facility with an onsite gym, walking trails, café, free parking and many employee activities
Scheduled events throughout the year that allow our employees, both current and retirees, to gather together and enjoy their time with their families and co-workers
Pride! When a storm strikes, Generac employees always rise to the occasion. Each time a storm hits, many employees volunteer their time with the customer support team or on the production line, while others go right into storm-affected areas to repair generators
Make a positive impact. Generac has always been community-minded and dedicated to giving back. The company proudly offers a Volunteer Time Off program, inviting team members to participate in charitable volunteer opportunities on company time
We believe in having fun. From minor celebrations to major events, our employees balance their work by building a strong culture of teamwork and collaboration through a variety of occasions, including our Fun Days
We’re an inclusive company that celebrates differences and keeps equity and respect at the forefront

Fulltime

Corporate Tax Senior Manager

NXTGEN are delighted to be working with a highly regarded and ambitious accounta...

Location

United Kingdom , Hertford

Salary:

60000.00 - 75000.00 GBP / Year

NXTGEN Recruitment

Expiration Date

Until further notice

Requirements

ACA, ACCA, CTA or equivalent qualified, or qualified by experience with significant corporate tax experience gained within a UK accountancy practice
Strong technical expertise across corporate tax compliance and advisory work and proven experience managing a client portfolio and leading complex assignments
A confident communicator with the ability to build relationships and influence stakeholders
demonstrable leadership experience, with a passion for developing and mentoring others
Commercial awareness and an interest in contributing to business growth, strategy and strong organisational skills with the ability to manage multiple priorities effectively

Job Responsibility

Managing a portfolio of corporate tax clients, delivering a mix of compliance and high level advisory services
Leading complex tax engagements, including group restructures, reorganisations, international considerations, and strategic planning projects
Acting as a trusted advisor to clients, building strong, long term relationships and understanding their commercial objectives
Reviewing complex corporation tax returns and ensuring the highest quality across all client deliverables
Leading client meetings, confidently presenting technical advice in a clear, commercial manner
Taking ownership of workflow planning, resource allocation, and ensuring delivery against deadlines and budgets
Monitoring work in progress, managing recoverability, and supporting fee discussions where required
Identifying scope changes and opportunities for additional services, contributing to revenue growth
Driving business development activity, including supporting proposals, attending meetings, and building an external network
Managing, mentoring, and developing team members, creating a high performing and collaborative team culture

What we offer

Real ownership of a high value and diverse corporate tax portfolio
Opportunity to shape and influence the direction of a growing tax team
Exposure to complex advisory work including restructures, reorganisations, and strategic tax planning
Clear and realistic progression pathway towards Director level
A collaborative, forward thinking environment with strong leadership support
The ability to work closely with Partners on growth strategy and key decisions
Competitive salary and benefits package with regular reviews
Ongoing professional development and support

Fulltime

Select Country

Senior Manager Corporate Quality Compliance

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?